Device product
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Z-1775-2022
Product summary
- Firm
- Covidien Llc
- Event
- Event 90766
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 US
- Official record key
device-enforcement:Z-1775-2022
Official wording
Reason: Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.
Code information: UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340
Distribution pattern: Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
Derived failure modes
-
Manufacturing or process control
manufacturing error