BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 4103537 · Received September 19, 2014

    Report

    Report Number
    1031452-2014-10151
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 2, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES, THAT THE CONSUMER COULD NOT LOWER THE BED RAIL ON ONE SIDE BECAUSE, THE GUIDE PIECE FROZE UP AND WOULD NOT MOVE TO ALLOW THE BED RAIL TO BE LOWERED. PROVIDER STATES, THAT THE CONSUMER HAD TO CALL 911 FOR ASSISTANCE. CONSUMER ADVISED PROVIDER THAT WHEN THE EMERGENCY HELP CAME THEY COULD NOT GET THE BED RAILS DOWN EITHER SO THEY MOVED THE BED AWAY FROM THE WALL AND LOWERED THE OTHER BED RAIL SO THE CONSUMER COULD BE REMOVED FROM THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585279 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS G5510

    Patients

    Seq Age Sex Outcome Treatment
    1 Other