BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2728865 · Received September 6, 2012

    Report

    Report Number
    1525712-2012-01363
    Event Type
    Malfunction
    Date Received
    September 6, 2012
    Report Date
    September 4, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TRACER MANUAL WHEELCHAIR, THE DATE CODE IS UNKNOWN, AGE IS UNKNOWN. 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. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE.

    Description of Event or Problem · 1

    DEALER STATED THAT THE T94HE LEG RESTS ARE NOT STAYING UP. NO REPORT OF ANY INJURY OR ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN TRACER

    Patients

    Seq Age Sex Outcome Treatment
    1 Other