BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR COMPONENTS

    MDR report key: 2662627 · Received July 20, 2012

    Report

    Report Number
    1525712-2012-01003
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Report Date
    July 18, 2012
    Manufacturer
    UNKNOWN
    Product Code
    KNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL T94HE. THE OWNER'S MANUAL PART NUMBER 1110546 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 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. ALLEGEDLY THE LEGRESTS ARE STUCK IN THE UP POSITION.

    Description of Event or Problem · 1

    DEALER STATES "THE LEGS ARE STUCK IN THE UP POSITION." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR COMPONENTS 890.3920 KNN UNKNOWN T94HE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other