BEUDAMED
    FDA Adverse Event Death Summary report: N

    BED-EX

    MDR report key: 224748 · Received May 20, 1999

    Report

    Report Number
    224748
    Event Type
    Death
    Date Received
    May 20, 1999
    Date of Event
    May 10, 1999
    Report Date
    May 20, 1999
    Manufacturer
    BED-EX
    Product Code
    KMI
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT GOT OUT OF BED DESPITE INSTRUCTIONS NOT TO. BED-EX DID NOT ALARM AT ALL OR DID NOT ALARM FOR PROLONGED TIME. ROOMMATE CALLED TO SAY PT HAD FALLEN. PT FOUND ON FLOOR, BLEEDING FROM CUT ON HEAD AND NON RESPONSIVE. CODE CALLED. UNABLE TO RESUSCITATE PT. IT IS POSSIBLE PT HAD LIFE THREATENING ARRHYTHMIA WHICH CAUSED THE FALL AND DEATH. NO AUTOPSY WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED-EX BED OCCUPANCY DEVICE KMI BED-EX * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death TELEMETRY MONITOR.