BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUETTE ICU MONITORS

    MDR report key: 305606 · Received November 21, 2000

    Report

    Report Number
    305606
    Event Type
    Injury
    Date Received
    November 21, 2000
    Date of Event
    November 10, 2000
    Report Date
    November 21, 2000
    Manufacturer
    GE (MARQUETTE) MEDICAL SYSTEMS
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPARENT FAILURE OF THE MARQUETTE MONITORS TO ALARM WHEN THE PT DEVELOPED ASYSTOLE FOR APPROX 15 SEC. THE PT'S FAMILY AT THE BEDSIDE ALERTED NURSING STAFF THAT THE MONITOR RATE WAS 0 AND THERE WAS A FLAT LINE. NURSING EVALUATED PT AND IMMEDIATELY INITIATED CPR/ACLS PROTOCOL. THE PT EXPIRED BUT NOT THOUGHT TO BE RELATED TO THE MONITOR FAILURE. PT HAD DNR ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUETTE ICU MONITORS CARDIAC MONITORS - SOLAR 8000 DRT GE (MARQUETTE) MEDICAL SYSTEMS SOLAR 8000 NI
    2 MARQUETTE ICU MONITORS CARDIAC MONITORS - SOLAR 8000 DRT GE (MARQUETTE) MEDICAL SYSTEMS TRAM-450XL *
    3 MARQUETTE ICU MONITORS CARDIAC MONITORS - SOLAR 8000 DRT GE (MARQUETTE) MEDICAL SYSTEMS TRAM-RAC4A *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening PT WAS ON BIPAP.