Device product
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
Z-0343-2022
Product summary
- Firm
- Covidien Llc
- Event
- Event 88987
- Status
- Terminated
- Classification
- Class I
- Quantity
- 278 total
- Official record key
device-enforcement:Z-0343-2022
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 - 10884521201415 Serial Numbers: 35B1700408 35B1700412 35B1700499 35B1700525
Distribution pattern: Worldwide distribution - US Nationwide.
Derived failure modes
-
Manufacturing or process control
Manufacturing assembly error