BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2843303 · Received November 22, 2012

    Report

    Report Number
    3004493922-2012-00516
    Event Type
    Malfunction
    Date Received
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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. OF NOTE: ANY ADDITIONAL INFORMATION WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    END USER STATES SHE WENT INTO A RECLINING POSITION, LEGS WON'T COME BACK DOWN. NO REPORT OF INJURY OR ILL EFFECT.

    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 62 Other