BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESIDENT BED

    MDR report key: 2469225 · Received February 21, 2012

    Report

    Report Number
    1824206-2012-00985
    Event Type
    Death
    Date Received
    February 21, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 9, 2012
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A HILL-ROM FIELD TECHNICIAN INSPECTED THE BED AND FOUND IT TO BE WORKING CORRECTLY WITH THE EXCEPTION OF THE SIDERAILS MAKING CONTACT WITH THE HARDPAN WHEN STORING THE SIDERAILS UNDER THE BED. HE NOTED THAT THE BED EXIT PAD AND MATTRESS USED BY THE FACILITY WERE NOT HILL-ROM PRODUCTS. THE BED EXIT PAD SLID WITH THE PT AND REMAINED UNDER HIM. THE RESIDENT LTC BED USER MANUAL STATES: THE USER OF MATTRESSES THAT ARE NOT SOLD BY HILL-ROM, MAY REDUCE THE EFFECTIVENESS OF THE SAFETY FEATURES AND SYSTEMS INCORPORATED INTO HILL-ROM BEDS. EVALUATE PTS FOR ENTRAPMENT RISK ACCORDING TO FACILITY PROTOCOL, AND MONITOR PTS APPROPRIATELY. MAKE SURE ALL SIDERAILS ARE FULLY LATCHED WHEN IN THE RAISED POSITION. FAILURE TO DO EITHER OF THESE COULD CAUSE SERIOUS INJURY OR DEATH. SIDERAILS ARE INTENDED TO BE A REMINDER TO THE PT OF THE UNIT'S EDGES, NOT A PT RESTRAINING DEVICE. WHEN APPROPRIATE, HILL-ROM RECOMMENDS THAT MEDICAL PERSONS DETERMINE THE CORRECT METHODS NECESSARY TO MAKE SURE A PT REMAINS SAFELY IN BED.

    Description of Event or Problem · 1

    THE FACILITY ADMINISTRATOR STATED THAT THE PT WAS FOUND ON THE FLOOR ON THE LEFT SIDE OF THE BED. THE RIGHT SIDE OF THE BED WAS AGAINST THE ROOM WALL. THE PT'S HEAD WAS BETWEEN THE SIDERAIL AND THE MATTRESS WITH THE PT'S NECK/CHIN AGAINST THE INSIDE OF THE LEFT SIDERAIL AND THE PT'S LEGS WERE BENT AT THE KNEES WITH FEET BEHIND AND TO THE RIGHT. THE NON HILL-ROM BED EXIT PAD WAS UNDER THE PT BUT HAD NOT ALARMED, WHEN THE PT WAS MOVED OFF OF THE BED EXIT DEVICE, IT BEGAN TO ALARM. THE NURSE PULLED THE CALL CORD FROM THE WALL AND CALLED A CODE. THEN 911 WAS CALLED AND EMTS ARRIVED AND TRANSPORTED THE PT TO THE EMERGENCY ROOM. THE PT ARRIVED IN THE EMERGENCY ROOM BUT EFFORTS TO RESUSCITATE WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESIDENT BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 870

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death