BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G.E. MEDICAL TELEMETRY

    MDR report key: 576377 · Received February 24, 2005

    Report

    Report Number
    576377
    Event Type
    Injury
    Date Received
    February 24, 2005
    Date of Event
    December 15, 2004
    Report Date
    December 20, 2004
    Manufacturer
    GE HEALTHCARE TECHNOLOGIES
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT ALLEGEDLY ALARMED VTACH AT 9:55 AM IN 2005. A CODE WAS CALLED AND MEDICATION WAS ADMINISTERED. THE STAFF QUESTIONED THE PT'S RHYTHM AND PT WAS DISCHARGED FROM THE TRANSMITTER AND ADMITTED TO THE DASH MONITOR. THE DASH MONITOR SHOWED A NORMAL SINUS RHYTHM. PT WAS ALSO ON SPO2 MONITORING. APEX PRO, CIC LOGS AND ECG STRIPS WERE COLLECTED FROM THE MONITORING EQUIPMENT. WAVEFORMS DISPLAYED ON THE ECG STRIPS RECEIVED ARE CONSISTENT WITH THOSE DISPLAYED IN A "VECSIM" MODE. THE VECSIM MODE IS USED DURING SYSTEM INSTALLATION. THE VECSIM MODE IS ENTERED AND EXITED WHEN A FIELD ENGINEER SENDS A COMMAND TO THE DEVICE THROUGH ITS PROGRAMMING PORT. IN ORDER FOR VECSIM TO BE PERSISTENT THROUGH A BATTERY CHANGE, A NON-VOLATILE MEMORY LOCATION IS READ AT POWER UP, AND ITS VALUE IS USED TO TELL THE TRANSCEIVER IF IT SHOULD ENTER THE VECSIM MODE. THE UNIT IN QUESTION WAS FOUND TO FREQUENTLY CORRUPT ITS NON-VOLATILE MEMORY LOCATIONS WHEN AN EXTREMELY LOW-VOLTAGE IS INSERTED. THE "VECSIM" MODE WAS NOT OBSERVED OR REPRODUCED DURING INVESTIGATION, BUT CORRUPTED MEMORY LOCATIONS WERE SEEN WHEN A BATTERY WITH LOW VOLTAGE WAS INSERTED. THE BELOW APEXPRO LOG FILES SHOW THAT THE TRANSCEIVER BATTERY WAS REPORTED "DEAD" JUST PRIOR TO THE INCIDENT. THIS LOW BATTERY VOLTAGE LIKELY LED TO A CORRUPT MEMORY LOCATION THAT INDICATED TO THE TRANSCEIVER THAT IT SHOULD ENTER "VECSIM" MODE. THE DEVICE IS STILL IN USE AND IS AT THE CUSTOMER'S FACILITY.

    Description of Event or Problem · 1

    PATIENT ON TELEMETRY MONITOR. MONITOR SHOWED V TACH EKG READING CONFIRMED AT BEDSIDE WITH DASH MONITOR. PT IN PERSISTENT VEGETATIVE STATE SO UNABLE TO ASSESS LOC. PULSE WEAK. PT CALLED A CHEMICAL CODE ONLY & MEDICATION MANAGEMENT INITIATED. MULTIPLE DOSES OF MEDS GIVEN WITH NO CHANGE. PULSE WAS VARIED BETWEEN BARELY PALPABLE TO STRONG. FAMILY DECIDED TO STOP CODE. STILL NO CHANGE IN EKG RHYTHM AFTER MEDS STOPPED. PT THEN PLACED ON HARD WIRED MONITOR. FOUND THAT PATIENT WAS IN NORMAL SINUS RHYTHM. PT CLOSELY MONITORED SUFFERED NO ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G.E. MEDICAL TELEMETRY TELEMETRY TRANSCEIVER DRT GE HEALTHCARE TECHNOLOGIES APEX PRO FH *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening