BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3243442 · Received July 23, 2013

    Report

    Report Number
    1031452-2013-01439
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 2, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER STATED THE END USER PLUGGED THE BED INTO AN UNGROUNDED OUTLET. DURING A STORM, LIGHTENING STRUCK AND THE END USER HEARD A POP. THE END USER STATED FIRE CAME OUT OF THE JUNCTION BOX CAUSING THE BED AND MATTRESS TO CATCH ON FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343360 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS BAR600IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other