BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEMS

    MDR report key: 554301 · Received September 15, 2004

    Report

    Report Number
    MW1033253
    Event Type
    Malfunction
    Date Received
    September 15, 2004
    Date of Event
    September 13, 2004
    Report Date
    September 15, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SINCE 7/04 THE TELEMETRY MONITOR CONTINUES TO GO BLANK WITH LOST MONITORING FOR A PERIOD OF TIME. THE MONITOR WILL SOMETIMES REBOOT ITSELF OR THE NURSE WILL REBOOT. CO RESPONSES TO REQUESTS FOR ASSISTANCE NOT TIMELY. REPEATED VISITS FROM THE CO HAD NOT RESULTED IN CORRECTION OF PROBLEM WITH, INDEPENDENTLY GOING DOWN & REBOOTING, LOSING HEART RATES, ALARM & WAVE REVIEW AND INABILITY TO RECORD STRIPS. DOWN TIME FREQUENTLY GREATER THAN 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS TELEMETRY SYSTEMS DRG PHILIPS MEDICAL SYSTEMS M3150A CENTRAL STATION *
    2 PHILIPS MEDICAL SYSTEMS TELEMETRY SYSTEMS DRG PHILIPS MEDICAL SYSTEMS M3150A CENTRAL STATION *
    3 PHILIPS MEDICAL SYSTEMS TELEMETRY SYSTEMS DRG PHILIPS MEDICAL SYSTEMS M3150A CENTRAL STATION *

    Patients

    Seq Age Sex Outcome Treatment
    1 *