BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGG

    MDR report key: 437693 · Received January 15, 2003

    Report

    Report Number
    437693
    Event Type
    Malfunction
    Date Received
    January 15, 2003
    Date of Event
    August 12, 2002
    Report Date
    August 12, 2002
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIAC MONITOR. THE PATIENT'S MONITOR SHOWED THE PATIENT WAS 100% PACED. THEN THE MONITOR STARTED SHOWING 7-8 SECOND PAUSES. THE NURSE THEN OBTAINED A 12-LEAD EKG AND DISCOVERED THE PATIENT WAS NOT HAVING PAUSES. THE EQUIPMENT WAS SHOWING A FAULTY READING. WHEN THE BOX AND WIRES WERE SWITCHED THE MONITOR READ CORRECTLY. THE CARDIAC MONITOR WAS CHECKED FOLLOWING THIS EVENT BY THE FACILITY'S BIOMEDICAL ENGINEERING DEPARTMENT WHO THEN ELECTED TO SEND THE DEVICE BACK TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGG MONITOR, CARDIAC DRT PHILIPS MEDICAL SYSTEMS M1002B *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other NO OTHER THERAPIES.