The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Draeger Medical
78 recalls • • Categories: Other Medical Devices, Patient Monitors, Diagnostic Equipment, Infusion Pumps, Surgical Instruments
Class I - Dangerous
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Class I - Dangerous
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Class I - Dangerous
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Class I - Dangerous
Unexpected shutdown while operating on battery power.
Class I - Dangerous
Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
Class I - Dangerous
Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I - Dangerous
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
Class I - Dangerous
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
Class I - Dangerous
Possible occlusion of filters due to manufacturing error.
Class I - Dangerous
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Class I - Dangerous
26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Class I - Dangerous
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
Class I - Dangerous
The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
Isolated episodes of leakage at the check valve were found
Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
Class I - Dangerous
Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is recommended. Updated Material Safety Data Sheets (MSDS) for Desflurane recommend wearing safety glasses when handling these substances.
Class I - Dangerous
The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
Class I - Dangerous
Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.
Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.
The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm in the current software. Devices used for patient transport will be a priority.
There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm.
Class I - Dangerous
The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Class I - Dangerous
the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, its parts can be loosened as a result of the magnetic force of the MRI.
Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Dr¿ger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR . A
Class I - Dangerous
Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in the motor unit broke and the lift arm fell down approximately 60 cm (23.6 inches).
Class I - Dangerous
During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.
Class I - Dangerous
The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.