BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICU MONITORING SYSTEM

    MDR report key: 93451 · Received May 21, 1997

    Report

    Report Number
    93451
    Event Type
    Death
    Date Received
    May 21, 1997
    Date of Event
    February 27, 1997
    Report Date
    May 15, 1997
    Manufacturer
    HEWLETT PACKARD WEST SALES REGION
    Product Code
    DRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON FEBRUARY 27, 1997, A 45 YEAR OLD MALE PT WAS ADMITTED VIA THE E.R. TO THE ICU AT ABOUT 1230 HOURS. ADMITTING DIAGNOSIS INCLUDES CHF, PNEUMONIA, SEIZURES, AND ALCOHOLIC CIRRHOSIS. AT APPROX 1858 HOURS PT WAS COINCIDENTALLY FOUND BY ICU STAFF IN A CODE CONDITION. A CODE WAS CALLED, STAFF RESPONDED, THE PT SURVIVED UNTIL APPROX 0900 HOURS ON FEBRUARY 28, 1997, AT WHICH TIME DEATH WAS PRONOUNCED. INVESTIGATION INTO THE MATTER ASCERTAINED THE ECG ALARM SWITCH LOCATED ON THE BEDSIDE MONITOR (HEWLETT PACKARD MODEL 78532B) WAS IN THE OFF POSITION. CONSEQUENTLY APPROPRIATE INFO COULD NOT BE TRANSMITTED TO THE CENTRAL MONITORING SYSTEM LOCATED AT THE NURSING STATION. FURTHERMORE THE CENTRAL SYSTEM COULD NOT GO INTO THE ALARM MODE THEREBY ALERTING NURSING PERSONNEL THAT THE PT WAS IN A CODE CONDITION. THIS EVENT IS VIEWED REPORTABLE FROM A) USER ERROR, AND B) EQUIPMENT DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICU MONITORING SYSTEM BEDSIDE MONITOR DRT HEWLETT PACKARD WEST SALES REGION 78532B *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death