BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2771328 · Received October 4, 2012

    Report

    Report Number
    9616091-2012-00420
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    October 2, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MODEL T422RFA, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY ONE MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1110545, REV.F(OCT-10), 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 MALFUNCTION HAS NOT BEEN CONFIRMED. A CALL WAS PLACED TO THE REPORTER OF THIS EVENT, TO DATE NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    A USER FACILITY HAS REPORTED THE LEG RESTS ON THIS CHAIR WILL NOT GO DOWN. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T422RFA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other