BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2802258 · Received October 23, 2012

    Report

    Report Number
    1525712-2012-01911
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 21, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL PATRIOT, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY ONE MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1088909 REV. E (FEB-09) 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 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 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 PATRIOT MECHANICAL WHEELCHAIR HAND RIMS WERE VERY SLIPPERY, AND THE UNIT WAS DIFFICULT TO PROPEL. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other