Device product
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Z-0678-2020
Product summary
- Event
- Event 84377
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 distributed in the US
- Official record key
device-enforcement:Z-0678-2020
Official wording
Reason: A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Code information: UDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680
Distribution pattern: The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.
Derived failure modes
-
Unknown
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.