Other Medical Devices

Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

An out of specification component may result in the device exhibiting torque output higher than the design specification.

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient