BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOPRIDER 6 RUNNER 14" HD

    MDR report key: 1147653 · Received August 22, 2008

    Report

    Report Number
    MW5008181
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    May 29, 2008
    Report Date
    August 14, 2008
    Manufacturer
    SHOPRIDER MOBILITY PRODUCTS, INC.
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SHOPRIDER 6 RUNNER 14" HD SHUTDOWN WHILE IN USE ON A HYDRAULIC LIFT AND STARTED ROLLING BACKWARDS WHILE SUSPENDED 4-5' (BASE TO GROUND) ENTERING SERVICE VEHICLE (BUS). OTHER PROBLEMS REPORTED PRIOR WITH ONE OR BOTH WHEELS (TRANSAXLES) SPINNING CAUSING MINOR ACCIDENTS IN HOME. MEDICARE STATED, MAX CAPACITY WEIGHT MANUAL STATED 350 NUMBER. SERVICEMAN PHONED IN BY PROVIDER TALKED WITH MFG TECH, WHO STATED WEIGHT AT DELIVERY = 420 NUMBER. MFG CHANGED SPECS ON WEBSITE TO REFLECT MAX WEIGHT AT 450 NUMBER. SECOND MEDICARE DURABLE MED EQUIPMENT COMPLAINT SENT. BOTH LISTED AS FINISHED PER PHONE. RECEIVED LETTER ON 8/13/2008 SENDING TO BENEFIT INTENSITY UNIT. MEDICARE INSTRUCTED TO APPLY FOR NEXT CLASSIFICATION OF VHD FOR 451 NUMBER INCREASE. PROVIDER MFG DID NOT SHIP PROPER OR ALLOW FOR ANY GRADE - ZERO DEGREE - NO SAFETY - MACHINE SHUT DOWN - OVERWEIGHT LIMIT ( MUST TAKE ZERO DEGREE'S INTO CONSIDERATION!) WAS REPRESENTED AS NEW WITH ELEVATED LEG REST (OPTION). DATES OF USE: 2007 - CURRENT. DIAGNOSIS OR REASON FOR USE: OSTEOARTHRITIS, OBESITY, HYPERTENSION, AND FIBROMYALGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOPRIDER 6 RUNNER 14" HD ELECTRIC WHEELCHAIR ITI SHOPRIDER MOBILITY PRODUCTS, INC. 6 RUNNER 14'' HD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| S