Device product
Puritan Bennett 980 Series Ventilator, 980S1ENDICU
Z-0340-2022
Product summary
- Firm
- Covidien Llc
- Event
- Event 88987
- Status
- Terminated
- Classification
- Class I
- Quantity
- 278 total
- Official record key
device-enforcement:Z-0340-2022
Official wording
Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Code information: GTIN/UDI - 10884521171114 Serial Numbers: 35B1700409 35B1700443 35B1700457 35B1700462 35B1700473 35B1700476 35B1700483 35B1700487 35B1700490 35B1700511 35B1700552 35B1700567 35B1700569 35B1700570
Distribution pattern: Worldwide distribution - US Nationwide.
Derived failure modes
-
Manufacturing or process control
Manufacturing assembly error