BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HILL-ROM 100 LOW BED

    MDR report key: 1024188 · Received March 27, 2008

    Report

    Report Number
    1824206-2008-00071
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    January 11, 2008
    Report Date
    January 11, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLAINT REVIEW IT WAS DETERMINED THAT THIS MALFUNCTION IS SIMILAR TO THE MALFUNCTION DOCUMENTED IN MDR 1824206-2008-00060 AND IS THEREFORE BEING REPORTED. THE CASTER BRAKES ON THIS BED ARE INDEPENDENT OF EACH OTHER, AND ALTHOUGH WE HAVE NOT SEEN MORE THAN ONE CASTER FAIL AT A TIME, IT IS LIKELY THAT IF MULTIPLE FAILURES WERE TO OCCUR SIMULTANEOUSLY, IT IS POSSIBLE THE BED COULD MOVE AND THEREFORE CAUSE SERIOUS INJURY.

    Description of Event or Problem · 1

    AN ACCOUNT STATED THAT WHEN THE BRAKES WERE SET AND THE BED WAS BUMPED THAT THE BRAKES BROKE AND WOULD NOT HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HILL-ROM 100 LOW BED AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 3930

    Patients

    Seq Age Sex Outcome Treatment
    1