BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 19163257 · Received April 23, 2024

    Report

    Report Number
    2249723-2024-01643
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    April 12, 2024
    Report Date
    January 31, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND AND THE FSE FOUND ERROR CODE 37 0X2EF0 FOLLOWED BY ERROR CODE 76. PERFORMED ALL MANIFOLD TEST, COMPRESSOR CYCLING AND OUTPUT, DRIVE REGULATOR CALIBRATION, AUTO FILL TEST RESULT PASSED, OPERATED ON CLINICAL MODE, TESTED PASS, NO VACUUM LEAK. ISSUE MOST LIKELY DUE TO APPLICATION, IAB BALLOON DIDN'T PLUG IN FULLY. USER TO MONITOR ON ISSUE. UNIT TESTED PASS IAW FACTORY SPEC AND UNIT HANDED TO USER.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE BY CUSTOMER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT AUTO FILL FAILED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941863 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown