BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 15565334 · Received October 7, 2022

    Report

    Report Number
    2249723-2022-02583
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 27, 2022
    Report Date
    February 27, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE ISSUE. THE FSE UPON INVESTIGATION, I DISCOVERED THE UNIT HAD BEEN DROPPED. DURING ANALYSIS, THE UNIT PASSES ALL LEAK TESTS. THE UNIT PASSES ALL BATTERY FUNCTION TESTS. THE DISPLAY HINGES ARE BENT AND BROKEN. REPLACED BOTH HINGES (D105-00-0138-01 AND D105-00-0138-02). FUNCTIONAL TESTING AND SAFETY CHECK TO FACTORY SPECIFICATIONS. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. THE UNIT RETURNED FOR CLINICAL USE.

    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 DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS SCREEN IS VERY DIFFICULT TO OPEN AND THE BATTERIES ARE DEPLETING TO FAST AS WELL AS A HELIUM LEAK. THERE WAS NO HARM REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289009 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 60 YR Female