BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILENT TECHNOLOGIES

    MDR report key: 311650 · Received January 8, 2001

    Report

    Report Number
    311650
    Event Type
    Injury
    Date Received
    January 8, 2001
    Date of Event
    March 11, 2000
    Report Date
    June 1, 2000
    Manufacturer
    AGILENT TECHNOLOGIES, INC
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WAS ON CARDIAC MONITOR, ECG, AND PULSE OXIMETRY. PT HAD PERMANENT PACEMAKER. MONITOR HAS A SWITCH TO SELECT "PACED" OR "NOT PACED" MODE. THE DEFAULT IS "NOT PACED". PT HAD A WORKING PERMANENT PACEMAKER. COVERING NURSE WAS IN NEXT ROOM MONITORING A 2ND PT BUT COULD OBSERVE SUBJECT PT AND CARDIAC MONITOR THROUGH A GLASS WINDOW THAT SEPARATED THE ROOMS. THE PT'S HEART STOPPED APPARENTLY DUE TO FAILURE OF VENTRICULAR MUSCLE TO PICK UP PACING SIGNAL, BUT SPIKES FROM THE WORKING PACEMAKER STILL APPEARED ON THE MONITOR. NURSE SAW SPIKES ON MONITOR AND THOUGHT THEY WERE THE QRS. SINCE THE MONITOR WAS SET BY DEFAULT IN THE "NOT PACED" MODE, THE MONITOR DID NOT ALARM WHEN THE PT'S HEART STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688 AGILENT TECHNOLOGIES MERLIN COMPONENT MONITORING SYSTEM DRT AGILENT TECHNOLOGIES, INC 1094B *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening