BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET CARDIOPULMONARY AG

    MDR report key: 3692870 · Received February 27, 2014

    Report

    Report Number
    3008355164-2014-00038
    Event Type
    Injury
    Date Received
    February 27, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRANSPORT THE USER RECEIVED A LOW BATTERY ALARM AND SHORTLY AFTER, THE UNIT POWERED OFF. HAND CRANKING WAS PERFORMED UNTIL THEY GOT TO THE JET BECAUSE THE INVERTER IN THE AMBULANCE WAS NOT WORKING. UPON ARRIVAL AT THE AIRCRAFT, THEY PLUGGED THE UNIT IN, AND IT FUNCTIONED AS NORMAL. NO PATIENT DEATH OR INJURY. (B)(4). PLEASE REFER MFR REPORT # 8010762-2014-00089.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122294 MAQUET CARDIOPULMONARY AG ROTAFLOW CONSOLE KFM MAQUET CARDIOPULMONARY AG 70102.8708 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other