BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 3902607 · Received May 9, 2014

    Report

    Report Number
    2249723-2014-00552
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARDIOSAVE IABP WAS REPLACED UNDER WARRANTY. THE ERROR LOGS WERE VERIFIED WITH THE RETURNED UNIT. THE EVAL RESULT IDENTIFIED THE ROOT CAUSE TO BE AN INTERMITTENT PROBLEM WITH THE FRONT END BOARD (PART NUMBER: 0670-00-0769). A CAPA WAS OPENED TO INVESTIGATE AND ADDRESS THIS ISSUE. THE INVESTIGATION RECOMMENDED TO REPLACE U102 MOSFET WITH A CLAMPING RECTIFIER SCHOTTKY DIODE IN THE BOARD. EFFECTIVENESS OF THE CORRECTIVE ACTION WAS VERIFIED AND CAPA WAS CLOSED. THE START UP PROBLEM ATTRIBUTED TO THE FRONT END BOARD ONLY OCCURS UPON A COLD START OF THE CARDIOSAVE SYSTEM. THIS DOES NOT EFFECT THERAPY. THERE IS NO ISSUE ONCE THE PUMP IS OPERATING. (B)(4).

    Description of Event or Problem · 1

    DURING IN-SERVICE TRAINING, THE COMPANY REP OBSERVED THAT THE IABP DID NOT START UP. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282240 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1