BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 16234010 · Received January 24, 2023

    Report

    Report Number
    2249723-2023-00397
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Date of Event
    September 11, 2020
    Report Date
    January 17, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE STM REPLACED THE HELIUM ACCESS PANEL (0333-00-0245-02) THEN COMPLETED PM SERVICE. ALL SAFETY, FUNCTIONALITY, AND CALIBRATION CHECKS WERE PERFORMED 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 DURING PREVENTATIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM), THE HELIUM ACCESS PANEL FOR THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS OBSERVED TO BE DAMAGED/CRACKED. IT WAS NOTED THAT THE IABP UNIT INVOLVED IS A RENTAL UNIT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403320 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