BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDCARE STAND-N-WEIGHT

    MDR report key: 1071745 · Received May 6, 2008

    Report

    Report Number
    2135150-2008-00002
    Event Type
    Other
    Date Received
    May 6, 2008
    Date of Event
    April 26, 2008
    Report Date
    May 6, 2008
    Manufacturer
    MEDCARE PRODUCTS, INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHEARING OF THE PIN IS LIKELY CAUSE BY LATERAL PRESSURE ON THE ACTUATOR. THIS COULD HAVE BEEN CAUSED BY IMPACT TO THE MOTOR, LATERAL PRESSURE OVER TIME OR SOMETHING PLACED BETWEEN THE ACTUATOR AND THE STAND MAST. THIS STAND WAS 8.5 YEARS OLD. THE ACTUATOR WAS REPLACED AND MAINTENANCE INSTRUCTED ABOUT THE IMPORTANCE OF AVOIDING LATERAL PRESSURE TO THE MOTOR AND TO TAKE THE STAND OUT OF SERVICE IF IT MAKES IRREGULAR NOISES OR SHAKES OR HAS A JERKING MOTION. SALES REP IS SCHEDULED TO MAKE AN IN SERVICE VISIT.

    Description of Event or Problem · 1

    DURING A TRANSFER, THE LOWER PART OF THE SCREW PIN ON THE ACTUATOR BENT AND SHEARED OFF OF THE MOTOR. THE RESIDENT WAS LOWERED TO THE GROUND WITH THE ASSISTANCE OF STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCARE STAND-N-WEIGHT SIT TO STAND LIFT FNG MEDCARE PRODUCTS, INC. 400005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other