Device product

Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

Z-0100-2019

September 20, 2018

Class I

Product summary

Firm: Maquet Datascope Corp - Cardiac Assist Division
Event: Event 81055
Status: Ongoing
Classification: Class I
Quantity: N/A
Official record key: device-enforcement:Z-0100-2019

Official wording

Reason: There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

Code information: UDI - 10607567108407 All Serial Numbers

Distribution pattern: US Nationwide; Internationally to 77 countries

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.