BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 15583778 · Received October 11, 2022

    Report

    Report Number
    2249723-2022-02628
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    October 6, 2022
    Report Date
    March 8, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE ISSUE. THE FSE REPORTED PHYSICAL DAMAGE TO PUMPS CASE AND DISPLAY. FSE REPLACED COIL CABLE (D012-00-1801), WHEEL ASEMBLY (D997-00-0588), 300 PSI CHECK VALVE (D103-00-0634), LCD UPPER FRAME (D406-00-0894), DISPLAY BEZEL (D380-00-0559), DISPLAY HINGE COVER(D380-00-0561), CONSOLE COVER(D441-00-0194), REAR HANDLE(D367-00-0114). NO PATIENT INVOLVED. UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TESTS. UNIT WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TRAINING, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS LOCKING MECHANISM NEEDS TO BE CHECKED. IT WAS DROPPED DURING TRAINING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483321 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 NA Unknown N/A.