BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4213580 · Received October 30, 2014

    Report

    Report Number
    3008262382-2014-01776
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 10, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY A DEALER THAT THE RECLINE BACK DOES NOT STAY IN THE RECLINED POSITION ON A MESMERISED POWER CHAIR. DEALERS CLAIMS THE HINGE MUST BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696009 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M51PSEMIRED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other