BEUDAMED
    FDA Adverse Event Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2821831 · Received November 6, 2012

    Report

    Report Number
    1525712-2012-02098
    Date Received
    November 6, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 6, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-CG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY FOUR YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1143190 REV. F (APR-08) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO 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 CONSUMER IS A (B)(6) MALE. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE PATIENT GAVE THE TILT COMMAND TO THE TDXSP-CG POWER WHEELCHAIR AND IT KEPT ON TILTING WITHOUT COMMAND. AS A RESULT, THE PATIENT HAD BOTH KNEES SPRAINED UPON GETTING OUT OF THE STILL TILTED UNIT. EMERGENCY MEDICAL ATTENTION WAS SOUGHT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 Other