BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2695210 · Received August 14, 2012

    Report

    Report Number
    9616091-2012-00251
    Event Type
    Malfunction
    Date Received
    August 14, 2012
    Report Date
    August 13, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL PR #(B)(4) ISSUED MFR REPORT #9616091-2012-00251. THE CORRECT MODEL NUMBER IS TREX20R. (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TREX20R, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR 5 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1110546 REV G (FEB-11) 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'S AGE, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TREX20R, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR 5 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1110546 REV G (FEB-11) 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'S AGE, 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

    DEALER CALLED STATING THAT CONSUMER BROUGHT IN THE 24" WHEEL ASSEMBLY FOR THE TREX20R MANUAL WHEELCHAIR AS THERE ARE ALLEGEDLY BROKEN SPOKES. THE SPOKES ALLEGEDLY BROKE WHILE THE CONSUMER WAS BEING PUSHED IN THE CHAIR.

    Description of Event or Problem · 1

    DEALER CALLED STATING THAT CONSUMER BROUGHT IN THE 24" WHEEL ASSEMBLY FOR THE TREX20R MANUAL WHEELCHAIR AS THERE ARE ALLEGEDLY BROKEN SPOKES. THE SPOKES ALLEGEDLY BROKE WHILE THE CONSUMER WAS BEING PUSHED IN THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX20R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other