BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP SYSTEM

    MDR report key: 4278626 · Received November 26, 2014

    Report

    Report Number
    8010762-2014-00773
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    October 6, 2011
    Report Date
    October 6, 2011
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2012, A CREDIT NOTE WAS ISSUED FOR THE BATTERIES. HOWEVER, NO REPAIR INFORMATION WAS PROVIDED. REFERENCE: COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, NEW REPLACEMENT BATTERIES (LOT 90009008, DATE CODE= 2010-12) WERE INSTALLED INSIDE FOUR(4) CARDIOHELP (SERIAL NUMBERS (B)(4), (B)(4), (B)(4),AND (B)(4)) MACHINES. AFTER THE BATTERIES WERE REPLACED AND THE UNITS WERE POWERED ON, THE UNITS DISPLAYED A "BATTERY DEFECTIVE" MESSAGE. ADDITIONALLY, THE UNITS WOULD NOT ACCEPT A CHARGE. NOTE: THE ORIGINAL BATTERIES IN THE UNITS WERE FROM THE SAME LOT (LOT 90009008, DATE CODE= 2010-12). THIS INCIDENT DID NOT OCCUR DURING USE. THIS MEDWATCH IS BEING SUBMITTED FOR SERIAL NUMBER (B)(4). MFR REPORT# 8010762-2014-00518 WILL BE USED FOR SERIAL NUMBER (B)(4). MFR REPORT# 8010762-2014-00771 WILL BE USED FOR SERIAL NUMBER (B)(4). MFR REPORT# 8010762-2014-00772 WILL BE USED FOR SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768717 CARDIOHELP SYSTEM HEART-LUNG,CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG 70104.8012

    Patients

    Seq Age Sex Outcome Treatment
    1