BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS MEDICAL SYSTEMS

    MDR report key: 640033 · Received October 3, 2005

    Report

    Report Number
    640033
    Event Type
    Injury
    Date Received
    October 3, 2005
    Date of Event
    July 14, 2005
    Report Date
    September 16, 2005
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FROM ED WITH CHEST PAIN AND SUBENDO INFARCTION. PLACED ON TELEMETERY. IN 05 STAFF OBSERVED FLAT LINE DISPLAYED ON TELEMETRY CENTRAL MONITOR SYSTEM. ALL STAFF REPORT THAT NO ALARMS WERE RECEIVED ON THEIR PAGERS. PATIENT FOUND UNRESPONSIVE WITH TELEMETRY LEADS OFF. CARDIAC ARREST CODE CALLED. UNSUCCESSFUL RESUSCITATION. A REVIEW OF PATIENT'S ECG RHYTHM HISTORY REVEALED THAT MONITORING CEASED DURING A "LEADS OFF" EPISODE. A RETROSPECTIVE REVIEW OF MONITORING SYSTEM LOG FILES REVEALED THAT 3 ALARMS WERE TRANSMITTED TO ALL PAGERS AT THE TIME OF THE EPISODE TO ALERT STAFF TO THE "LEADS OFF" CONDITION. CONFIRMATION OF RECEIPT BY BEEPERS IS NOT POSSIBLE. NO FURTHER MONITORING TOOK PLACE. THE PATIENT WAS FOUND UNRESPONSIVE APPROXIMATELY 75 MINUTES AFTER THE "LEADS OFF" EPISODE BEGAN. THE MONITORING SYSTEM VENDOR (PHILIPS) EVALUATED IDENTIFIED THAT CERTAIN "LEADS OFF" CONDITION, IN PARTICULAR, WHEN THE RL LEAD IS DISCONNECTED, FAIL TO CAUSE ALARMS TO BE SENT TO PAGERS (CENTRAL STATION ALARMS ARE ACTIVATED) ALTHOUGH THE SYSTEM IS CONFIGURED TO DO SO. PHILIPS' DIAGNOSTIC EVALUATION CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS TELEMETRY CARDIAC MONITORING SYSTEM DRG PHILIPS MEDICAL SYSTEMS M2604 *
    2 PHILIPS MEDICAL SYSTEMS PHILIPS DATABASE SERVER MHX PHILIPS MEDICAL SYSTEMS 31548 *
    3 PHILIPS MEDICAL SYSTEMS PHILIPS INTELLIVUE INFORMATION CENTER MHX PHILIPS MEDICAL SYSTEMS M3150B *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Life Threatening