BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3083780 · Received April 29, 2013

    Report

    Report Number
    1031452-2013-00819
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 4, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    PROVIDER STATES BROKE AT THE WELD ON HEAD SPRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183292 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS BED4-1633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other