BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSOLE, ROTAFLOW

    MDR report key: 2150427 · Received June 24, 2011

    Report

    Report Number
    2150427
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MAQUET
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    THE MACHINE INDICATES IT IS FULLY CHARGED WHEN IN FACT IT IS NOT. IT WILL RUN FOR 15 MINUTES INSTEAD OF THE TWO HOURS A FULL CHARGE WOULD PROVIDE. SINCE THIS IS A LIFE SUPPORT DEVICE, THIS IS A CRITICAL ISSUE. THE MFR RESPONSE FOR THE ROTAFLOW CONSOLE WAS THE MFR WAS UNABLE TO REPRODUCE THE PROBLEM, BUT GENERATED A CUSTOMER COMPLAINT. WE ARE WAITING TO HEAR BACK FROM HEADQUARTERS BEFORE MOVING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSOLE, ROTAFLOW ROTAFLOW CONSOLE KFM MAQUET * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *