BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2781873 · Received October 11, 2012

    Report

    Report Number
    1525712-2012-01794
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 10, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TA4, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 10 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1110545 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 REPORTER OF THIS EVENT HAS BEEN CONTACTED FOR INFORMATION REGARDING THIS INCIDENT. THE DEVICE IS USED INSIDE AND OUTSIDE. HE HAS OWNED THIS DEVICE FOR 10 YEARS. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CASTER IS BEING REPLACED AS REPORTED BY THE REPORTER. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    AN END USER STATES THE FRONT RIGHT CASTER CAME OFF OF THE DEVICE. IT WAS LEARNED IN SPEAKING WITH THE END USER THAT HE WAS ABLE TO RIDE HOME ON WHAT WAS LEFT OF THE CASTER. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET TA4

    Patients

    Seq Age Sex Outcome Treatment
    1 39 Other