BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 4140921 · Received October 3, 2014

    Report

    Report Number
    1031452-2014-12089
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 17, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER, SOME OF THE RIVETS ON THE HEAD SECTIONS OF THE BED HAVE POPPED OUT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619135 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other