BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 4920725 · Received July 15, 2015

    Report

    Report Number
    3008355164-2015-00141
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 18, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TRANSPORT, UPON UNPLUGGING THE DEVICE, THE BATTERY QUICKLY DRAINED AND THE LOW ALARM SOUNDED. THE DEVICE WAS PLUGGED BACK IN AND EXCHANGED FOR ANOTHER. NO REPORTED PATIENT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460709 ROTAFLOW CENTRIFUGAL PUMP SYSTEM KFM MAQUET CARDIOPULMONARY AG US US-PLUG ICU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention