BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3964492 · Received July 29, 2014

    Report

    Report Number
    1031452-2014-04641
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 24, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE BED SPARKED AND CAUSED THE BED TO LOSE ALL CONTROL FUNCTIONS. CUSTOMER NOT CERTAIN WHAT COMPONENT OF THE BED SPARKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441184 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS G5410IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other