BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVC BARIATRIC BED RAIL 9153641597

    MDR report key: 4811606 · Received June 2, 2015

    Report

    Report Number
    1031452-2015-13871
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Report Date
    May 4, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOR THE PATIENT A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    PROVIDER ALLEGES THAT THE HEAD SECTION THAT GOES UP BY ITSELF ON A BAR600IVC BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355778 IVC BARIATRIC BED RAIL 9153641597 BARIATRIC BED OSI INVACARE FLORIDA OPERATIONS BAR600IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other