BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3071967 · Received April 22, 2013

    Report

    Report Number
    1031452-2013-00768
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 28, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE FRAME BEING BENT AT THE CROSSBAR ON AN IH820-3MDLX BED. THIS EVENT COULD CAUSE POSSIBLE PRODUCT INSTABILITY AND THE POTENTIAL FOR NOT PERMITTING THE BED TO MAINTAIN ITS INTENDED WEIGHT-BEARING STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172354 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS IH820-3MDLX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other