BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2808335 · Received October 29, 2012

    Report

    Report Number
    9615350-2012-00004
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MOTION CONCEPTS
    Product Code
    IOR
    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 PBE1916, SERIAL NUMBER/DATE CODE AND AGE OF PRODUCT ARE UNKNOWN. 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 MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER CALLED STATING THAT THE SHELL OF THE PBE1916 INVACARE MATRX BACK IS ALLEGEDLY CRACKED AT THE BRACKET ATTACHMENT. THIS SEAT BACK IS ON A (B)(4) WHEELCHAIR. OEM NOTIFICATION BEING SENT TO (B)(4). NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR MOTION CONCEPTS PBE1916

    Patients

    Seq Age Sex Outcome Treatment
    1 Other