BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2833639 · Received November 15, 2012

    Report

    Report Number
    3002416487-2012-00002
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 6, 2012
    Manufacturer
    INVACARE CANADA
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL MVPS, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY ONE MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1106638 REV. B (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 IS (B)(6). HOWEVER, HER HEIGHT IS UNKNOWN. THE CONSUME'S 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)(6) - THE DEALER REPORTED THAT THE MVPS MECHANICAL WHEELCHAIR CASTER DETACHED FROM THE UNIT WHILE THE DOUBLE AMPUTEE PATIENT WAS USING IT. THERE WAS NO INJURY REPORTED. TO FIND. NO INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 Other