BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3061240 · Received April 16, 2013

    Report

    Report Number
    1031452-2013-00719
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 19, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE CONSUMER THAT THE 5410IVC BED HAND PENDANT WAS MALFUNCTIONING, RESULTING IN THE PATIENT BEING LEFT STUCK IN THE UPPER POSITION. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163554 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5410IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 90 Other