BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 8864275 · Received August 6, 2019

    Report

    Report Number
    2249723-2019-01206
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 1, 2019
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS REVIEWED AND NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT WERE NOTED. A GETINGE SERVICE TERRITORY MANAGER (STM) EVALUATED THE IABP AND WAS ABLE TO VERIFY THE ISSUE OF THE UNIT NOT CHARGING 1 OF THE BATTERIES REGARDLESS OF WHICH PORT THE BATTERY WAS IN. THE OTHER BATTERY WAS CHARGING JUST FINE WITH NO ISSUES. THE STM TRIED THE BAD BATTERY IN ANOTHER CARDIOSAVE UNIT AND IT STILL WILL NOT CHARGE. THE STM REPLACED BOTH BATTERIES SO THEY ARE ON THE SAME REPLACEMENT CYCLE AND BOTH BATTERIES ARE CHARGING AND THE UNIT IS ABLE TO RUN BATTERY POWER ON BOTH BATTERIES. ALL FUNCTIONAL AND SAFETY TESTS WERE PASSED TO MEET FACTORY SPECIFICATIONS AND THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE BATTERIES ON THE NEW CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) IS NOT HOLDING A CHARGE OR CHARGING. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THIS EVENT OCCURRED; HOWEVER, THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661753 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1