Device product
Puritan Bennett 980 Series Ventilator, 980U1ENASAA
Z-0342-2022
Product summary
- Firm
- Covidien Llc
- Event
- Event 88987
- Status
- Terminated
- Classification
- Class I
- Quantity
- 278 total
- Official record key
device-enforcement:Z-0342-2022
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 - 10884521201385 Serial Numbers: 35B1700252 35B1700365 35B1700399 35B1700407 35B1700489 35B1700505 35B1700513 35B1700555 35B1700557 35B1700562 35B1700563 35B1700565 35B1700566 35B1700605 35B1700612 35B1700634 35B1700651 35B1700662 35B1700663
Distribution pattern: Worldwide distribution - US Nationwide.
Derived failure modes
-
Manufacturing or process control
Manufacturing assembly error