BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2802233 · Received October 23, 2012

    Report

    Report Number
    3004493922-2012-00428
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 21, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 20 MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1143206 REV. G (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 A (B)(6) FEMALE. HOWEVER, 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). IT WAS REPORTED BY THE CONSUMER THAT THE PRONTO M41 POWER WHEELCHAIR WOULD START AT NORMAL SPEED TOO SOON AFTER SLOWING DOWN. UPON ASSESSMENT OF THE UNIT, THE TECHNICIAN FOUND THAT THE OFF BOARD CHARGER, THE JOYSTICK, AND THE CONTROLLER TO BE FAULTY. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41

    Patients

    Seq Age Sex Outcome Treatment
    1 63 Other