BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2676675 · Received July 31, 2012

    Report

    Report Number
    1525712-2012-01088
    Event Type
    Malfunction
    Date Received
    July 31, 2012
    Report Date
    July 31, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL STORM TORQUE 3G, SERIAL NUMBER/DATE CODE IS UNKNOWN. 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) FEMALE WHOSE HEIGHT AND WEIGHT ARE UNKNOWN. 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.

    Description of Event or Problem · 1

    CONSUMER STATED "OWNS THE STORM TORQUE 3G SERIES WHEELCHAIR. ON THE FOOT PLATE OF THE CHAIR, THE BUSHING SLEEVE (1110742) THAT HOLDS THE FOOT PLATE TO THE LEG KEEPS BREAKING. THEY HAVE REPLACED THIS PART 3 TIMES. CONSUMER TO CONTACT DEALER TO REPLACE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET STORM TORQUE 3G

    Patients

    Seq Age Sex Outcome Treatment
    1 69 Other