Patient Monitors

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.

GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.

GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.

Product has the potential to be contaminated with Burholderia cepacia.

Product has the potential to be contaminated with Burholderia cepacia.

Device vented gas below the stated pressure.