BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 16242361 · Received January 25, 2023

    Report

    Report Number
    2249723-2023-00454
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Report Date
    January 19, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE GETINGE FIELD SERVICE ENGINEER (FSE) WHO DISCOVERED THE ISSUE, REPLACED THE 4 MISSING SCREWS (0212-12-0605). 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 REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS SCREEN SUPPORT WAS PLACED ON THE CONSOLE WITHOUT SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203096 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN.