BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEMS

    MDR report key: 582391 · Received March 15, 2005

    Report

    Report Number
    582391
    Event Type
    Malfunction
    Date Received
    March 15, 2005
    Date of Event
    March 10, 2005
    Report Date
    March 11, 2005
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    THE CENTRAL PATIENT MONITOR WAS MIS-CALCULATING THE PATIENT'S HEART RATE. THE ACTUAL HEART RATE WAS 40 BPM, AND THE INDICATED HEART RATE WAS 180 BPM. THE RN ATTEMPTED TO SELECT ANOTHER LEAD, BUT THE MALFUNCTIONING CENTRAL MONITOR WOULD ONLY DISPLAY LEAD II. THE CENTRAL MONITOR WAS RE-BOOTED, AND MODIFIED LEAD III WAS SELECTED TO RESOLVE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS CENTRAL PATIENT MONITOR DRT PHILIPS MEDICAL SYSTEMS M3150A *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR