BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3944327 · Received July 18, 2014

    Report

    Report Number
    3003433498-2014-00138
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 11, 2014
    Manufacturer
    INVACARE CONTINUING CARE GROUP
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CS7 BED - THE HARDWARE FOR THE ASSIST RAILS WILL NOT STAY TIGHTEN PER DEALER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421311 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE CONTINUING CARE GROUP IHCS7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other