BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3894845 · Received June 25, 2014

    Report

    Report Number
    1031452-2014-02523
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 27, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER ALLEGED THAT THE HEAD MOTOR HOUSING FELL APART CAUSING THE HEAD SECTION TO FALL FROM THE RAISED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370493 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 OSI INVACARE FLORIDA OPERATIONS BAR600IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 Other