BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGILENT TECHNOLOGIES/VIRIDIA

    MDR report key: 299763 · Received October 5, 2000

    Report

    Report Number
    299763
    Event Type
    Death
    Date Received
    October 5, 2000
    Date of Event
    May 28, 2000
    Report Date
    October 2, 2000
    Manufacturer
    AGILENT TECHNOLOGIES INC
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT WENT INTO AN EXTENDED EPISODE OF VENTRICULAR FIBRILLATION WHILE ON CARDIAC MONITORING WITH TELEMETRY. THE AUDIBLE ALARM (A SPEAKER) AT THE CENTRAL MONITOR FAILED TO ANNUNCIATE, AND AS A RESULT, THE EVENT WENT UNNOTICED BY CLINICAL PERSONNEL, AND THE VENTRICULAR FIBRILLATION PROGRESSED TO AN UNATTENDED CARDIOPULMONARY ARREST. THE PAPER RECORDING THAT WAS GENERATED AT THE TIME OF THE EVENT BY THE MONITOR CLEARLY DOCUMENTS THE SERIES OF EVENTS LEADING TO THE ARREST. EXAMINATION OF THE MONITORING SYSTEM REVEALED THE FOLLOWING: THE CONNECTOR FROM THE ALARM SPEAKER TO THE COMPUTER GENERATING THE ALARM WAS A SIMPLE "BANANA PLUG" WITH NO MEANS FOR FIXATION OR SECURE CONNECTION TO THE BODY OF THE COMPUTER. THE INITIAL INSTALLATION OF THE MONITOR BY TECHNICIANS FROM AGILENT TECHNOLOGIES IN DECEMBER OF 1999 WAS NOT DONE IN ACCORDANCE WITH AGILENT'S WRITTEN PROCEDURE (SEE ATTACHMENT B) WHICH CALLS FOR THE SPEAKER WIRE TO BE ATTACHED TO A "SECURE" CONNECTOR, I.E., ONE THAT IS FIXED TO THE BODY OF THE MONITOR WITH A THREADED ONNECTION, WITH A ELECTRICAL TIE WRAP. THIS PROCEDURE, EVEN WHEN PERFORMED ACCORDING TO THE MFR'S INSTRUCTIONS, FAILS TO SECURE THE SPEAKER CONNECTOR, THE KEYBOARD CONNECTOR, AND THE MOUSE CONNECTOR SUFFICIENTLY TO PREVENT THESE DEVICES FROM BECOMING DISCONNECTED. INADVERTENT DISCONNECTION OF THE MOUSE OR THE KEYBOARD MAY CAUSE THE COMPUTER TO "FREEZE" AND THEREBY FAIL TO IDENTIFY AND ANNUNCIATE WHEN AN ARRYTHMIA OCCURS. FURTHER EXAMINATION OF THE SYSTEM REVEALED THAT AT THE TIME THE SYSTEM WAS ASSEMBLED AND INSTALLED BY AGILENT TECHNOLOGIES, CRITICAL COMPONENTS, E.G. THE COMPUTER AND MONITOR FOR THE SYSTEM, WERE PLUGGED INTO THE "SURGE CONTROL" SIDE OF THE UNINTERRUPTABLE POWER SUPPLY, RATHER THAN THE UPS POWER SIDE, AND WOULD HAVE FAILED IMMEDIATELY IN THE EVENT OF A POWER OUTAGE. TESTING OF THE UPS REVEALED THAT WITH THE COMPUTER AND MONITOR CONNECTED TO THE UPS AND THE PRINTER DISCONNECTED (MINIMUM OPERABLE CONFIGURATION) THE UPS PROVIDED ONLY FIVE MINUTES OF BACK-UP POWER. IT IS FACILITY'S OPINION THAT THIS LENGTH OF TIME IS AN INADEQUATE SAFE INTERVAL FOR CLINICIANS TO RESPOND TO SUCH AN OUTAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILENT TECHNOLOGIES/VIRIDIA CARDIAC MONITOR/ALARM DRT AGILENT TECHNOLOGIES INC M3150A *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death