BEUDAMED
    FDA Adverse Event Death Summary report: N

    V-CUE DYNAMIC AIR THERAPY UNIT

    MDR report key: 1031472 · Received April 17, 2008

    Report

    Report Number
    1031472
    Event Type
    Death
    Date Received
    April 17, 2008
    Date of Event
    March 29, 2008
    Report Date
    April 16, 2008
    Manufacturer
    HILL-ROM ST PAUL
    Product Code
    FNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS FOUND WEDGED BETWEEN THE BED RAILINGS AND MATTRESS, FACING OUTWARD, ON A V-CUE DYNAMIC AIR THERAPY SPECIALTY BED WHICH HAD A "ROTATE" FUNCTION. THE PT WAS WEARING A BEDSIDE CONTINUOUS PULSE OXIMETER WHICH HAD ALARMED AND THE PT'S OXYGEN SATURATION WAS 54% AND PULSE 33 BEATS PER MINUTE. THE NURSE ATTEMPTED TO PULL THE PT BACK ON THE BED MATTRESS, BUT WAS UNABLE TO AS THE PT WAS WEDGED FIRMLY BETWEEN MATTRESS AND SIDERAIL. THE CPR MODE OF THE BED WAS ACTIVATED AND THE MATTRESS DEFLATED. THE PT WAS CYANOTIC, FLACCID AND UNRESPONSIVE TO PAINFUL STIMULI. THE PT EXPIRED FIVE MINUTES AFTER THE EVENT WAS DISCOVERED. ADDENDUM: THE V-CUE THERAPY UNIT IS PLACED ON A HOSPITAL BED. THE V-CUE IS RENTED FROM HILL-ROM. THE BED FOR THIS EVENT IS A HILL-ROM: YEAR - 1998, MODEL # ADVANCE SERIES 1165.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CUE DYNAMIC AIR THERAPY UNIT SPECIALTY BED FNM HILL-ROM ST PAUL RUM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death