Device product
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
Z-1628-2021
Product summary
- Event
- Event 87753
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1628-2021
Official wording
Reason: Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
Code information: Serial Number: V305622168DB9, V30562335D64E, V305626872849, V30562903EA6A
Distribution pattern: Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan
Derived failure modes
-
Unknown
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.