BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16272078 · Received January 31, 2023

    Report

    Report Number
    2249723-2023-00691
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    April 12, 2021
    Report Date
    March 13, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A PREVIOUSLY SCHEDULED SERVICE CALL, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A BROKEN CHASSIS BIN. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THIS UNIT. THE FSE NOTED THE BROKEN CHASSIS BIN DURING A PREVIOUSLY SCHEDULED SERVICE CALL. THE CHASSIS BIN (0441-00-0196) WAS REPLACED. THE FSE COMPLETED ALL SAFETY, FUNCTIONALITY AND CALIBRATION CHECKS AND ALL TESTS PASSED TO FACTORY SPECIFICATIONS. THE IABP UNIT WAS CLEARED FOR CLINICAL USE AND RELEASED TO THE CUSTOMER. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4).

    Description of Event or Problem · 0

    IT WAS DISCOVERED THAT DURING SERVICE VISIT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A BROKEN CHASSIS BIN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104663 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown