BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2760226 · Received September 26, 2012

    Report

    Report Number
    1525712-2012-01605
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 25, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA INITIATED FOR THIS ISSUE. MODEL M94-C, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 1 YEAR, 2 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1122145, REV. I(OCT-08), 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. A CALL WAS PLACED TO THE REPORTER OF THE EVENT, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED. THEREFORE, CONSUMER'S 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 IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER ADVISED THAT THE RIGHT MOTOR AND GEARBOX PULLS TO THE RIGHT AND THE CABLE THAT IS HARDWIRED INTO IT IS LOOSE. THE CHAIR WAS ORDERED (B)(6) 2011, BUT WAS NOT DELIVERED TO THE END USER UNTIL (B)(6) 2012, DUE TO END USER BEING IN A FACILITY. DEALER ADVISED THAT THE CHAIR SAT IN THEIR HOLDING AREA IN THE MEANTIME. ITEM TO BE REPAIRED UNDER WARRANTY. NO REPORTS OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M94-C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other