BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16233620 · Received January 24, 2023

    Report

    Report Number
    2249723-2023-00393
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Report Date
    February 3, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 NOTICED THAT THE LEFT MONITOR HINGE COVER WAS MISSING. FURTHER INSPECTION REVEALED THAT THE MONITOR HAD SUFFERED MUCH DAMAGE TO THE HINGE CORNER. THE STM REPLACED THE UPPER DISPLAY BEZEL (0380-00-0559), UPPER HINGE COVER DISPLAY (0380-00-0561), UPPER INSIDE BADGE LABEL (0334-00-1809), CARDIOSAVE LABEL (0334-00-1810-01), UPPER DISPLAY MON-VIDEO POWER CABLE (0012-00-1817), LEFT DISPLAY HINGE (0105-00-0138-01), RIGHT DISPLAY HINGE (0105-00-0138-02), AND THE DISPLAY SEALS. THE STM COMPLETED ALL SAFETY, FUNCTIONALITY, AND CALIBRATION CHECKS WHICH 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

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS MISSING A HINGE COVER AND BENT HINGES ON DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033364 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