BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX MATE K500

    MDR report key: 4939061 · Received July 20, 2015

    Report

    Report Number
    MW5044710
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 20, 2015
    Manufacturer
    KLC SERVICES
    Product Code
    BXB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE UNPLUGGING A CPM MACHINE, THE TRANSFORMER CAME APART EXPOSING THE WIRING INSIDE. THE STAFF MEMBER SOMEHOW CONTACTED THE WIRING AND WAS SHOCKED. NO HARM TO THE STAFF MEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469105 FLEX MATE K500 EXERCISER BXB KLC SERVICES K500

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR