BEUDAMED
    FDA Adverse Event Death Summary report: N

    CCU P895

    MDR report key: 1695909 · Received May 18, 2010

    Report

    Report Number
    1824206-2010-07356
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    February 20, 2007
    Report Date
    April 12, 2007
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH INSPECTED THE BED AND FOUND THAT THE BED WAS FUNCTIONING PROPERLY AND THE BED WAS NOT CONSIDERED TO CONTRIBUTE TO THE INCIDENT. PURSUANT TO OUR RESPONSE TO WARNING LETTER 2008-DT-04, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.

    Description of Event or Problem · 1

    THE ACCOUNT'S RISK MGR ALLEGED THAT A PT WAS RESTRAINED AS A FALL PRECAUTION AND DURING RESTRAINT/FALL ROUNDS, THE PRIMARY CARE NURSE DISCOVERED THE PT BETWEEN THE HEAD AND FOOT SIDE RAILS, WITH BUTTOCKS AND EXTENDED LEG ON FLOOR, PT HAD EXPIRED. ACCOUNT ALLEGED THAT THE PT'S BACK WAS AGAINST THE BED, WITH VEST RESTRAINT IN PLACE AROUND TORSO (STRAPS INTACT). ACCOUNT STATED THAT THE CAUSE OF DEATH WAS NOT DETERMINED AND THAT THE PT WAS A TERMINAL HOSPICE PT. ACCOUNT SPECULATED THAT THE VEST RESTRAINT, IN CONJUNCTION WITH THE PT WEIGHT HANGING OFF THE BED MAY HAVE CUT OFF THE PT'S CIRCULATION OR AIRWAY. ACCOUNT STATED THAT SINCE AN AUTOPSY WAS NOT CONDUCTED, AS A REQUEST BY THE PT FAMILY, THEY CANNOT STATE THE EXACT CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCU P895 A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P895

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death