BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2221230 · Received August 24, 2011

    Report

    Report Number
    1525712-2011-00450
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Report Date
    August 19, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL TDXSI-CG. THE CONSUMER WAS UNABLE TO LOOK AT THE BACK OF THE CHAIR TO GET THE SERIAL NUMBER. NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS WHEEL CHAIR BECAUSE THE DEALER, WOODS MEDICAL, CAME OUT AND ADJUSTED THE POWER CHAIR. THE WHEEL CHAIR IS NO LONGER TIPPING FORWARD. IT IS UNKNOWN WHICH PARTS WERE REPLACED TO RESOLVE THIS ISSUE. HOWEVER, THIS COMPLAINT MAY BE THE RESULT OF A MALFUNCTIONING STABILITY LOCK. IF THE STABILITY LOCK FEATURE DOES NOT ENGAGE PROPERLY, THE WHEELCHAIR MAY EXHIBIT THE ERRATIC TENDENCIES DESCRIBED BY THE CONSUMER. MALFUNCTIONS OF THIS TYPE CAN BE THE RESULT OF IMPROPER ADJUSTMENT DURING DEVICE MANUFACTURING, NORMAL WEAR, OR POST PRODUCTION DAMAGE. UNUSUAL USER HABITS OR IMPROPER PRODUCT USE MAY PRECIPITATE FAILURES OF THIS TYPE. REGULAR MAINTENANCE, INCLUDING PERIODIC INSPECTION AS DEFINED IN THE LITERATURE FOR THE DEVICE CAN DETECT ISSUES OF THIS TYPE.

    Description of Event or Problem · 1

    THE CONSUMER STATES WHEN SHE IS GOING DOWN A RAMP IN HER POWER CHAIR, THE WHEELS IN THE BACK ALLEGEDLY LIFT OFF THE GROUND. WHILE GOING DOWN A DRIVEWAY, THE SIDE ALLEGEDLY LIFTS OFF THE GROUND AND ANOTHER PERSON MUST HOLD IT DOWN TO KEEP THE CHAIR FROM TIPPING. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TDXSI-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 60 Other