BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2843304 · Received November 22, 2012

    Report

    Report Number
    1525712-2012-02262
    Event Type
    Malfunction
    Date Received
    November 22, 2012
    Report Date
    November 18, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IS UNKNOWN, SERIAL NUMBER/DATE CODE IS UNKNOWN AND IS APPROXIMATELY OF AN UNKNOWN AGE. THE OWNER'S MANUAL 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 CONSUME'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUME'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS 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

    AN INCIDENT WAS REPORTED THAT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE UNIT WON'T CALIBRATE. IN SPEAKING WITH THE REPORTER IT WAS LEARNED THAT THERE WAS NO INJURY. THE EVENT IS LIKELY RELATED TO A JOYSTICK AND IF ANY FURTHER INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other