BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS DIGITAL TELEMETRY

    MDR report key: 2618604 · Received June 17, 2012

    Report

    Report Number
    3023361-2012-00029
    Event Type
    Death
    Date Received
    June 17, 2012
    Date of Event
    May 19, 2012
    Report Date
    June 15, 2012
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SPACELABS FIELD SERVICE ENGINEER (FSE) TESTED THE SUBJECT DEVICE AT THE CUSTOMER'S SITE AND CONFIRMED THE DEVICE WORKED TO SPECIFICATIONS AND ALL ALARMS OCCURRED CORRECTLY. THE CUSTOMER HAD QUESTIONS IF THE INTESYS CLINICAL SUITE (ICS) G2 SYSTEM COULD DETERMINE ALARMS WERE GENERATED OR TURNED OFF AFTER A PATIENT WAS DISCHARGED. THE FSE TRAINED THE BIOMED ON HOW TO RETRIEVE ICS DATA. THE FSE NOTED THAT, IF ALARMS HAVE BEEN TURNED OFF IN THE MODULE LOCATED IN THE TELEMETRY MONITOR, ICS DOES NOT LOG ANY CHANGES OF ALARM SETTINGS AND ICS RECEIVES NO ALARM NOTIFICATIONS. A REVIEW OF THE WAVEFORM DATA AND ALARMS SHOWED NO ALARMS WERE RECEIVED BETWEEN 4 AM AND 5 AM DURING THE LOW ECG RATE AND ASYSTOLE EVENTS ON THE PATIENT. THE ICS SHOWED ALARMS BEFORE 4 AM AND AFTER 5 AM. IT APPEARS THAT ALARMS MAY HAVE BEEN TURNED OFF BETWEEN 4 AM AND 5 AM. HOWEVER, WE CANNOT CONFIRM THIS BECAUSE THE CUSTOMER USED THE MONITOR AND MODULE WITH A DIFFERENT PATIENT AFTER THE INCIDENT, WHICH PURGED THE ALARM SETTINGS AND DATA FROM THE SYSTEM. THE CUSTOMER CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE MONITORING SYSTEM. THEY ARE CONTINUING TO USE THE DEVICE TO MONITOR PATIENTS. IT IS SPACELABS' POLICY TO SUBMIT A MEDICAL DEVICE REPORT WHENEVER WE BECOME AWARE OF THE DEATH OF A PATIENT CONNECTED TO ONE OF OUR DEVICES. WE HAVE CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AND CONSIDER THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT DIED WHEN A SPACELABS TELEMETRY MONITOR WAS IN USE. THE CUSTOMER HAD QUESTIONS REGARDING ALARMS AND ALARM SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS DIGITAL TELEMETRY TELEMETRY DSI SPACELABS MEDICAL INC. 90478

    Patients

    Seq Age Sex Outcome Treatment
    1 Death TELEMETRY TRANSMITTER (B)(4)