BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 MOTOR ADVANCED BED

    MDR report key: 1061772 · Received June 13, 2008

    Report

    Report Number
    1824206-2008-02663
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 30, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THAT THE BED FUNCTIONED PROPERLY, AND HE COULD NOT DUPLICATE THE MALFUNCTION. HE EXAMINED THE CPR HARDWARE AS WELL AS THE BED FUNCTIONS, AND EVERYTHING WAS OPERATING AS DESIGNED.

    Description of Event or Problem · 1

    HOSPITAL BIOMED REPORTED THAT A PATIENT ALLEGED THAT THE HEAD SECTION OF THE BED MOVED DOWNWARD UNINTENTIONALLY TO THE LOWEST POSITION WHILE HE WAS IN THE BED. HE REPORTED THAT THE PATIENT AND HIS WIFE WERE THE ONLY ONES IN THE ROOM WHEN THIS OCCURRED, HOWEVER, THE PATIENT'S WIFE WAS ASLEEP AT THE TIME. THE PATIENT ALLEGED THAT THIS UNINTENTIONAL MOVEMENT HURT HIS BACK. NURSE MANAGER STATED THAT THE PATIENT RECEIVED AN X-RAY, AND THERE WERE NO INJURIES INDICATED, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 MOTOR ADVANCED BED AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 1155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other