Device product
Getinge Flow-e Anesthesia System, Part No. 6887900
Z-0961-2023
Product summary
- Event
- Event 91339
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 8.016 Total (7.766 OUS; 250 US)
- Official record key
device-enforcement:Z-0961-2023
Official wording
Reason: Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
Code information: Part # UDI 6887900 07325710010457 Serial Numbers 50012-50197 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.
Distribution pattern: US nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.
Derived failure modes
-
Device software or design
software bug