BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPM MACHINE

    MDR report key: 5001318 · Received August 5, 2015

    Report

    Report Number
    MW5055339
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 5, 2015
    Manufacturer
    KLC SERVICES INC.
    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

    WHEN UNPLUGGING A CPM MACHINE, THE TRANSFORMER CAME APART EXPOSING THE WIRING INSIDE. THE TRANSFORMER SHORTED AND CAUSED SPARKING. NO HARM TO STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517607 CPM MACHINE CPM MACHINE BXB KLC SERVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1