BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2759908 · Received September 26, 2012

    Report

    Report Number
    1525712-2012-01595
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 24, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL CXE, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 4 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1127114 REV. D (MAR-07) 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 FEMALE CONSUMER'S AGE IS (B)(6). THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER ADVISED PROBLEMS ARE THAT THE QUICK RELEASE AXLES ARE COMING OUT AND ACTUALLY FALLING OFF. DEALER ADVISED THAT ONE TIME THE END USER WAS ON A BUS WHEN THE WHEELS CAME OFF AND WAS TRANSPORTED HOME "BY THE FIRE PEOPLE." DEALER ADVISED THAT THE BOLTS THAT HOLD THE WHEELS ON KEEP COMING OUT. DEALER ADVISED END USER WAS GOING UP A RAMP AND THE WHEEL WENT FORWARD AND SHE ALMOST WENT OUT OF THE CHAIR. THIS CAUSED HER BACK TO GO FORWARD. DEALER DOES NOT KNOW WHAT THE INJURY WAS AND THAT THE END USER ALSO REPORTED BEING INJURED SEVERAL TIMES PREVIOUSLY. UNKNOWN IF ANY MEDICAL TREATMENT HAS BEEN ADMINISTERED. NO REPORTS OF OTHER PROPERTY DAMAGE AT THIS TIME. DEALER ADVISED THE CHAIR WAS REPAIRED TWICE IN JUNE AND NO OTHER RECORD OF REPAIRS. DEALER ADVISED THE END USER DOES NOT SPEAK AND REQUIRES A TTY COMMUNICATION. MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 Other