BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOPRIDER

    MDR report key: 1781537 · Received July 22, 2010

    Report

    Report Number
    MW5016848
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    May 19, 2010
    Report Date
    July 20, 2010
    Manufacturer
    SHOPRIDER MOBILITY PRODUCTS INC.
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CHAIR WAS PICKED UP FOR REPAIR ON 06/28/2010. WHILE RIDING THE CHAIR UP A RAMP ON (B)(6) 2010, THE LEFT MOTOR FAILED AND RIGHT MOTOR CONTINUED TO OPERATE DRIVING THE CHAIR INTO THE RAILING. FORTUNATELY, THE RAILING HELD THE CHAIR FROM GOING OVER THE EDGE OF A 4FOOT DROP WHICH WOULD HAVE CAUSED SERIOUS INJURY OR DEATH. (B)(4). THIS CHAIR WAS DELIVERED TO US ON 05/28/2009 WITH A ONE YEAR WARRANTY. AFTER SEVERAL CALLS TO THE COMPANY STARTING ON (B)(6) 2010, IT WAS FINALLY PICKED UP. ON CHECKING IT OUT, THE BRAKE ON ONE SIDE AGAIN DID NOT HOLD WHEN THE POWER WAS TURNED OFF, CAUSING IT TO ROTATE WHEN TRYING TO GET OUT OF IT. IT WAS NOT ACCEPTED AND RETURNED TO (B)(4). THE COMPANY IS NOW SAYING THE CHAIR IS NOT COVERED BY THE WARRANTY AND IS BILLING (B)(6) AND ME FOR THIS REPAIR. THE WARRANTY CLEARLY STATES YEAR. THIS CERTAINLY LOOKS LIKE (B)(6) FRAUD TO ME, BUT I AM NOT AN ATTORNEY. THIS IS A DANGEROUS PIECE OF EQUIPMENT THAT WILL EVENTUALLY INJURE SOMEONE SERIOUSLY. IT IS NOW (B)(6) 2010 AND OUR CHAIR HAS STILL NOT BEEN RETURNED. FORTUNATELY, THEY DID PROVIDE A LOANER CHAIR FOR USE WHICH WE HAVE HAD SINCE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOPRIDER TROOPER POWER CHAIR ITI SHOPRIDER MOBILITY PRODUCTS INC. UL8W36

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening