BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRIDIA TELEMETRY SYSTEM

    MDR report key: 824097 · Received February 27, 2007

    Report

    Report Number
    824097
    Event Type
    Death
    Date Received
    February 27, 2007
    Date of Event
    February 2, 2007
    Report Date
    February 23, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, NA
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DELAYED RESPONSE TO LETHAL CARDIAC RHYTHM, WITH POTENTIAL CONTRIBUTION BY TELEMETRY MONITORING SOFTWARE ALARM ISSUES. A WOMAN ADMITTED FOR GENERAL WEAKNESS AND SHORTNESS OF BREATH. TREATED WITH ANTIBIOTICS AND BLOOD TRANSFUSIONS. THE DAY PRIOR TO DISCHARGE, AT 0920, TELEMETRY MONITOR (PHILIPS SOFTWARE PRODUCT) REVEALED VENTRICULAR FIBRILLATION ALARM ACTIVATED (PER PHILIPS' LOG). THE LOG REFLECTS THAT A DOUBLE CLICK WAS PERFORMED TO SILENCE THE ALARM 15 SECS LATER. THE LOG DOES NOT REFLECT A RE-ALARM FOR VENTRICULAR FIBRILLATION UNTIL 0928, DESPITE PERSISTENT VENTRICULAR FIBRILLATION RHYTHM ON THE MONITOR. TELEMETRY STAFF RESPONDED TO A CALL FOR ASSISTANCE WHEN THE PT WAS FOUND UNRESPONSIVE. STAFF REPORT GLANCING AT THE MONITOR AND SEEING THE VISUAL RED ALERT FOR VENTRICULAR FIBRILLATION FROZEN IN PLACE AND NO AUDIBLE ALARM. RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND PT EXPIRED. TESTS BY MEDICAL CENTER OF THE PHILIPS' ALARM SYSTEM REVEALED SPONTANEOUS EPISODES OF LATCHED ALARMS, IN WHICH THE ALARM SILENCED ITSELF AFTER ONLY THREE PULSES. REPORTED TO PHILIPS FOR THEIR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRIDIA TELEMETRY SYSTEM TELEMETRY SYSTEM MHX PHILIPS MEDICAL SYSTEMS, NA M3155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death