BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3961528 · Received July 28, 2014

    Report

    Report Number
    1031452-2014-04498
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    June 17, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    BEDS ARE UNSAFE, SIDE RAILS DON'T GO UP AND DOWN WITH THE HEAD SECTION, RAILS ARE VERY HIGH IN THE UP POSITION WHEN BED AT THE LOWEST CAUSING PATIENT TO CLIMB OVER THE RAILS . WHEN RAILS RELEASED TO LOWER THEY DESCEND QUICKLY, AFRAID OF HANDS GETTING CAUGHT, THE RAILS ARE TALLER THAN THE BED STANDARD MATTRESS HEIGHT AT LOWEST POINT, LOCKING SCREWS FOR HEAD AND FOOT SECTION DO NOT ALIGN. SIDE RAIL PREDRILLED HOLES DON'T LINE UP , BED ENDS RATTLE WITH ANY MOVEMENT OF BED, MOTOR SECTION NOT BOLTED SECURELY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437606 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS G5510

    Patients

    Seq Age Sex Outcome Treatment
    1 Other