BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 4231892 · Received November 6, 2014

    Report

    Report Number
    1031452-2014-17813
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 17, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THAT ONE OF THE LEGS ON THE BED IS BOWING OUTWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715993 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 OSI INVACARE FLORIDA OPERATIONS BAR600IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other