BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSACARE BED

    MDR report key: 2011864 · Received March 4, 2011

    Report

    Report Number
    1824206-2011-01252
    Event Type
    Death
    Date Received
    March 4, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 8, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN STATED THAT HE TESTED THE PT POSITIONING MONITOR (PPM) SYSTEM FOR THE BED AND FOUND IT TO BE WORKING PROPERLY. THE TECHNICIAN FOUND THE BED SCALE WAS ZEROED WHILE THE PT WAS IN THE BED AND THE BED EXIT WAS NOT SET. THE TECHNICIAN ALSO DISCOVERED THAT A SIDECOMM COMMUNICATION CABLE WAS NOT CONNECTED FROM THE BED TO THE ACCOUNTS NURSE CALL SYSTEM. ADDITIONALLY THE TECHNICIAN INSPECTED ALL OF THE SIDERAILS AND FOUND THEM TO BE OPERATING PROPERLY. THE ACCOUNT WOULD NOT RELEASE INFO REGARDING THE PT OR IF THE PT DIED AS A RESULT OF THE FALL. VERSACARE BED USER MANUAL STATES: THE BED EXIT ALARM SYSTEM SHOULD BE ZEROED BEFORE PUTTING THE PT ON THE BED. VERSACARE BED USER MANUAL STATES: THE BED EXIT DOES NOT ALARM AND ALL THREE MODE INDICATORS ARE FLASHING, REMOVE THE PT AND ZERO THE BED EXIT SYSTEM. VERSACARE BED USER MANUAL STATES: WARNING: A COMMUNICATION CABLE MUST BE USED FOR BEDS THAT HAVE NURSE CALL. FAILURE TO DO COULD CAUSE PT INJURY. FOR BEDS THAT HAVE NURSE CALL SYSTEMS, A COMMUNICATION CABLE MUST BE CONNECTED BETWEEN THE BED AND FACILITY COMMUNICATION SYSTEM.

    Description of Event or Problem · 1

    THE DIRECTOR OF PT SERVICES ALLEGED THAT ON (B)(6), 2011, A PT FELL OUT OF BED AND WAS FOUND ON THE FLOOR AND THE PT EXPIRED. THERE WERE NO WITNESSES. THE ATTENDING NURSE TOLD THE DIRECTOR THAT THE BED EXIT ON THE BED DID NOT ALARM AND THREE BED EXIT LIGHTS WERE FLASHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death