BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNICARE COMNPONENT MINITORING SYSTEM

    MDR report key: 37745 · Received September 4, 1996

    Report

    Report Number
    37745
    Event Type
    Death
    Date Received
    September 4, 1996
    Date of Event
    August 6, 1996
    Report Date
    September 3, 1996
    Manufacturer
    HEWLETT-PACKARD CO.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS FOUND UNRESPONSIVE IN RESPIRATORY ARREST. THE NURSES CLAIM THAT THE SPO2 PROBE HAD SLIPPED OFF HIS FINGER, BUT THE MONITOR WAS NOT ALARMING FOR SPO2 NONPULSATILE. THE NURSING STAFF HAD LAST CHECKED ON THE PT ABOUT TEN MINUTES BEFORE THE INCIDENT. THE PT HAD AN EXTERNAL PACING DEVICE. ARRHYTHMIA STRIPS FROM THE CENTRAL STATION WHICH WERE PRINTED FROM ALARM HISTORY INDICATE A THREE STAR BRADY ALARM. THE PT WAS RESUSCITATED AND TAKEN TO CARDIO-VASCULAR ICU WHERE HE DIED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNICARE COMNPONENT MINITORING SYSTEM COMPONENT MONITORING SYSTEM DRT HEWLETT-PACKARD CO. M1205A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death