BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2874813 · Received December 16, 2012

    Report

    Report Number
    1525712-2012-03076
    Event Type
    Malfunction
    Date Received
    December 16, 2012
    Date of Event
    November 16, 2012
    Report Date
    December 15, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL SOLARA3G, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY NINE MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1154295 REV. C (DEC-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 A MALE, AND WEIGHS (B)(6). HOWEVER, AGE, AND HEIGHT ARE 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)(4) - THE DEALER REPORTED THAT THE SOLARA3G MECHANICAL WHEELCHAIR RIGHT SIDE OF THE HANDLE WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other