BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3844620 · Received June 3, 2014

    Report

    Report Number
    1031452-2014-01893
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 26, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT A SMALL PIECE OF METAL, NEAR THE HEAD MOTOR MOUNT, SNAPPED OFF OF A BAR600IVC BARIATRIC BED WHILE THE END USER WAS OCCUPYING THE BED IN AN ELEVATED POSITION. THE HEAD SECTION DROPPED, JARRING THE USER. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324184 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS BAR600IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other