BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCELCARE BARIATRIC BED FRAME

    MDR report key: 1482851 · Received September 22, 2009

    Report

    Report Number
    1045510-2009-00021
    Event Type
    Death
    Date Received
    September 22, 2009
    Date of Event
    May 5, 2009
    Report Date
    May 5, 2009
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT REGARDING THE EXCELCARE BARIATRIC BED THAT INDICATED THAT THE DEVICE MAY HAVE REASONABLY CONTRIBUTED TO A PT'S DEATH. IT WAS REPORTED BY THE NURSE MGR THAT THE PT WENT TO ANOTHER HOSPITAL FOR A LUNG SCAN IN 2009. WHEN THE PT CAME BACK TO THE ORIGINAL HOSPITAL, HE WAS SHORT OF BREATH. THE STAFF REPORTED THAT THE HEAD OF THE FRAME ON THE EXCEL CARE BARIATRIC BED WOULD NOT STAY UP. THEY ATTEMPTED TO USE WEDGES TO KEEP HIM ELEVATED TO ASSIST HIS BREATHING. THE STAFF STATED THAT THEY COULD NOT GET ENOUGH WEDGES UNDER HIM. HIS DEATH WAS FROM ACUTE RESPIRATORY DISTRESS. THE INVESTIGATION INTO THE ROOT CAUSE OF THE EVENT CONCLUDED THAT AN INSUFFICIENT WELD PENETRATION ON THE HEAD ACTUATOR MOTOR MOUNT CAUSED THE MOTOR TO MOVE OUT OF ITS SPECIFIED POSITION. THE MOVEMENT OF THE MOTOR ENGAGED THE CPR RELEASE FUNCTION VIA A CABLE, WHICH ENGAGED A RELEASE MECHANISM ON THE HEAD ACTUATOR. THE CPR RELEASE LEVEL IS DESIGNED TO LAY THE HEAD OF THE BED FLAT TO AID IN THE ADMINISTRATION OF CPR. THE LEVER THAT ACTIVATES THE CPR FEATURE WAS NOT ACTIVATED BY THE USER. THE CPR RELEASE LEVER IS DESIGNED TO ONLY ALLOW THE HEAD OF BED TO LOWER WHILE THE LEVER IS PULLED (PULLING THE CABLE). THE MOTOR PULLING THE CABLE MEANT THE RELEASE WAS ALWAYS ENGAGED. TO THE USER, THE BED WOULD SEEM UNABLE TO KEEP THE HEAD OF BED ELEVATED EVEN THOUGH THE LEVER WAS NOT ACTIVATED. CORRECTIVE AND PREVENTATIVE ACTION IS BEING IMPLEMENTED TO CORRECT THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELCARE BARIATRIC BED FRAME AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM MANUFACTURING, INC. P610

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death