BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE

    MDR report key: 1960020 · Received December 28, 2010

    Report

    Report Number
    1960020
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    November 21, 2010
    Report Date
    December 28, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHILIPS, PATIENT INFORMATION CENTER (PIC) COMPUTER WHICH DISPLAYS 16 PATIENT'S TELEMETRY WAVE FORMS FROZE FOR A FEW MINUTES, THE SYSTEM WAS THEN REBOOTED. THE REBOOTING PROCESS TOOK ABOUT 5 MINUTES. SHORTLY AFTER THE DISPLAY MONITOR CAME BACK ON, IT WAS NOTED THAT ONE PATIENT HAD BRADYCARDIA. THIS PATIENT WAS AN UNRESPONSIVE DNR PATIENT, FOR WHICH COMFORT MEASURES ONLY WERE BEING ADMINISTERED. THE PATIENT EXPIRED ABOUT ONE HOUR LATER.HEALTH PROFESSIONAL'S IMPRESSION: IT WAS DETERMINED THAT THE PATIENT WAS RECEIVING COMFORT MEASURES ONLY AND WAS AT THE END OF LIFE PRIOR TO THE INCIDENT. HOWEVER, THERE WERE 15 OTHER PATIENTS THAT WERE AT RISK DURING THIS PERIOD FOR WHICH WE WERE UNABLE TO VIEW THEIR WAVE FORMS. THERE WERE NO ADVERSE OUTCOMES TO THE OTHER 15 PATIENTS.MANUFACTURER RESPONSE FOR MONITOR, CENTRAL, PHYSIOLOGICAL, TELEMETRY: WAITING FOR RESPONSE FROM FIELD SERVICE REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MONITOR, CENTRAL, PHYSIOLOGICAL, TELEMETRY MHX PHILIPS MEDICAL SYSTEMS M3155 RELEASE G.0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR