BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMANUFACTURED BED

    MDR report key: 1007047 · Received March 3, 2008

    Report

    Report Number
    1824206-2008-00042
    Event Type
    Death
    Date Received
    March 3, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 21, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RISK MANAGER REPORTED THAT THERE WAS A PT ENTRAPMENT DEATH IN 2008 AT 3:10AM. THE PT WAS AN HOSPICE PT. SHE WAS ATTACHED TO AN EXTERNAL BED EXIT SYSTEM BUT HAD REMOVED THE SENSORS FROM HERSELF. SHE WAS FOUND WITH BOTH FEET ON THE FLOOR AND THE RIGHT SIDE OF HER CHEST LOCATED BETWEEN A PRO2000 MATTRESS MANUFACTURED BY MEDLINE AND THE HEAD SIDERAIL. (ZONE 3 ENTRAPMENT). THE HILL-ROM TECHNICIAN FOUND NO MALFUNCTIONS WITH THE BED BUT DID FIND THAT THE NON-HILL-ROM MATTRESS WAS SET TO A MAXIMUM INFLATE SETTINGS. IT IS UNCLEAR WHETHER THIS CONTRIBUTED TO THE EVENT. HE ALSO FOUND THAT THE BED WAS NOT EQUIPPED WITH THE RECOMMENDED SIDERAIL INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMANUFACTURED BED AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 8400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death