BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2542501 · Received April 20, 2012

    Report

    Report Number
    9615350-2012-00001
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    January 6, 2012
    Report Date
    April 19, 2012
    Manufacturer
    MOTION CONCEPTS
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TRX-LPTR(CG), SERIAL NUMBER/DATE CODE (B)(4). 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 FEMALE, (B)(6). THE CONSUMERS 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. CONSUMERS ATTORNEY STATED THAT THE CONSUMER FELL FROM A VEHICLE PLATFORM DUE TO AN UNSPECIFIED MALFUNCTION OF THE POWER CHAIR.

    Description of Event or Problem · 1

    LETTER FROM ATTORNEY ALLEGED MALFUNCTION OF POWERED WHEELCHAIR. UNDETERMINED INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI MOTION CONCEPTS TRX-LPTR(CG)

    Patients

    Seq Age Sex Outcome Treatment
    1 63 Other