BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXERCISER

    MDR report key: 12241 · Received March 24, 1994

    Report

    Report Number
    MW1001198
    Event Type
    Malfunction
    Date Received
    March 24, 1994
    Report Date
    March 8, 1994
    Manufacturer
    BIODYNAMIC TECHNOLOGIES OF FLORIDA
    Product Code
    BXB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DEVICE IS POWERED BY 24 V AC (TRANSFORMER IN MIDDLE OF POWER CORD) THROUGH A 120 V AC CEE-22 MALE RECEPTACLE. A 120 V SOURCE COULD EASILY BE PLUGGED INTO UNIT. FUSE VALUE NOT MARKED. CO CALLED ON 3/8/94. RPTR WAS INFORMED THEY NO LONGER MADE UNIT OR MARKETED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXERCISER EXERCISER, CPM BXB BIODYNAMIC TECHNOLOGIES OF FLORIDA PARAFLEX 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 *