BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 16267839 · Received January 30, 2023

    Report

    Report Number
    2249723-2023-00333
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Report Date
    January 24, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO INVESTIGATE. THE STM EVALUATED THE IABP UNIT AND VERIFIED THE REPORTED ISSUE AND NOTED THAT THE CONSOLE WHEEL ASSEMBLY WAS DAMAGED DUE TO IMPROPER TRANSPORT OF THE CONSOLE. THE STM ORDERED THE NECESSARY PARTS THEN RETURNED AT A LATER DATE AND INSTALLED THE WHEEL ASSEMBLY (0997-00-0588). THE STM NOTED THAT AFTER REPAIRS, THE CONSOLE WOULD INSERT PROPERLY INTO THE CART. SUBSEQUENTLY, THE STM 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 REPORTED THAT , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS WHEELS DO NOT RETRACT COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403089 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