BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2742741 · Received September 13, 2012

    Report

    Report Number
    1525712-2012-01419
    Event Type
    Malfunction
    Date Received
    September 13, 2012
    Report Date
    September 11, 2012
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL RIIBMWDV, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 12 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1081229 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE FEMALE CONSUMER'S AGE IS (B)(6). THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    "END USER ALLEGED THAT THE JOYSTICK IS NOT RESPONDING. (B)(6) STATES THEN WHEN YOU GO TO TURN THE JOYSTICK TO ANY DIRECTION IT DID NOT RESPOND. IT WILL NOT GO STRAIGHT NOR THE DRIVE THE CHAIR AT ALL. (B)(6) STATED THAT THE CHAIR MADE A COUPLE OF HOLES IN THE DRY WALL AND TOOK OFF A LITTLE OF THE PAINT FROM THE DOORWAYS AS WELL BEFORE THE CHAIR STOPPED WORKING FOR HIM. (B)(6) IS HIS FINANCE WHO USES THE CHAIR. (B)(6) STATED THAT THEY HAVE NOT USED THE CHAIR IN 2 YEARS BECAUSE IT DOES NOT WORK. (B)(6) ALSO STATED THAT IT ALL DID NOT STOP AT ALL ONCE, THAT IT WOULD WORK THEN STOP THEN WORK AND STOP BEFORE IT COMPLETELY STOPPED WORKING ALL TOGETHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE S00B136291

    Patients

    Seq Age Sex Outcome Treatment
    1 46 Other