BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3902391 · Received June 30, 2014

    Report

    Report Number
    1031452-2014-02666
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    RIGHT RAIL IS BROKEN BY THE ADJUSTMENT KNOB. END USER USES THE RAILS FOR SUPPORT AND TO TRANSFER OUT OF BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381015 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5410IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other