BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3110157 · Received May 13, 2013

    Report

    Report Number
    1031452-2013-00891
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Report Date
    April 17, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A BROKEN CASTER ON A BAR600IVC BARIATRIC BED. THIS COMPROMISES THE WEIGHT-BEARING STATUS OF THE BED AND CREATES THE POTENTIAL FOR A FALLING INJURY FROM AN UNEVEN BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209858 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 OSI INVACARE FLORIDA OPERATIONS BAR600IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other