BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS DIGITAL TELEMETRY TRANSMITTER

    MDR report key: 4220034 · Received November 3, 2014

    Report

    Report Number
    3010157426-2014-00068
    Event Type
    Death
    Date Received
    November 3, 2014
    Date of Event
    October 3, 2014
    Report Date
    September 14, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT OF FAILURE TO ALARM FOR VF INVOLVES THE ECG ALGORITHM LOCATED IN THE TELEMETRY RECEIVER MODULE (MODEL 90478). THE MODULE PROCESSES ECG SIGNALS RECEIVED FROM THE TELEMETRY TRANSMITTER (MODEL 90341-50), DETERMINES ALARM STATUS, AND SENDS ALARM MESSAGES FOR DISPLAY TO THE TELEMETRY CENTRAL MONITOR (MODEL 91387-38). ON SITE TESTING OF THE INVOLVED DEVICES BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THAT ALL EQUIPMENT WORKED TO SPECIFICATIONS. THE TESTING WAS WITNESSED BY A FACILITY STAFF MEMBER. THE DATE AND TIME OF THE EVENT WAS (B)(6) 2014 AT 11:23 A.M. SNAPSHOTS OF CLINICAL DATA FROM THE RETROSPECTIVE DATABASE PROVIDED BY THE FACILITY INDICATE ECG SUSPEND PROCESSING HAD BEEN ENABLED BY THE CUSTOMER AT 11:14:43 A.M. WHEN ECG SUSPEND PROCESSING IS ENABLED, DATA ANALYSIS AND TRANSFER ARE SUSPENDED. HR IS DISPLAYED AS ??? FOR TELEMETRY, THE ¿NO ALARMS¿ ICON IS LIT, AND THE ECG SUSPEND MESSAGE DISPLAYS. THIS FEATURE PROVIDES VISUAL INDICATORS ON THE TELEMETRY CENTRAL MONITOR THAT ECG ALARMS ARE OFF, WHICH IS WHY THERE WAS NO ALARM PROCESSING FOR THE EPISODE OF VENTRICULAR FIBRILLATION. ECG SUSPEND PROCESSING IS FULLY DESCRIBED IN SPACELABS CLINICAL PARAMETERS OPERATIONS MANUAL, WHICH WAS PROVIDED TO THE CUSTOMER AT THE TIME OF EQUIPMENT PURCHASE. THIS FEATURE IS ENGAGED AND DISENGAGED AT THE CENTRAL MONITOR FOR TELEMETRY PATIENTS BY CLINICAL STAFF AS THEY DETERMINE CARE NEEDS, SUCH AS PATIENT SHOWERS OR ELECTRODE REPLACEMENT. SPACELABS WILL OFFER SUPPLEMENTAL TRAINING TO THE CUSTOMER ON THE OPERATION OF ECG SUSPEND PROCESSING. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT OF FAILURE TO ALARM FOR VF INVOLVES THE ECG ALGORITHM LOCATED IN THE TELEMETRY RECEIVER MODULE (MODEL 90478). THE MODULE PROCESSES ECG SIGNALS RECEIVED FROM THE TELEMETRY TRANSMITTER(MODEL 90341-50), DETERMINES ALARM STATUS, AND SENDS ALARM MESSAGES FOR DISPLAY TO THE TELEMETRY CENTRAL MONITOR (MODEL 91387-38). ON SITE TESTING OF THE INVOLVED DEVICES BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THAT ALL EQUIPMENT WORKED TO SPECIFICATIONS. THE TESTING WAS WITNESSED BY A FACILITY STAFF MEMBER. INVESTIGATION IS UNDERWAY. WE WILL FILE A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS CONCLUDED. PLACEHOLDER.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF); HOWEVER, THE CENTRAL MONITOR DID NOT ALARM. THIS EVENT OCCURRED AT 11:23 A.M. (B)(6) 2014. TELEMETRY DEVICES WERE REMOVED FROM THE PATIENT AT 11:27 A.M. FOR RESUSCITATION OF THE PATIENT, WHO PASSED AWAY.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF); HOWEVER, THE CENTRAL MONITOR DID NOT ALARM. THIS EVENT OCCURRED AT 11:23 A.M. (B)(6), 2014. TELEMETRY DEVICES WERE REMOVED FROM THE PATIENT AT 11:27 A.M. FOR RESUSCITATION OF THE PATIENT, WHO PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703734 SPACELABS DIGITAL TELEMETRY TRANSMITTER TELEMETRY TRANSMITTER DSI SPACELABS HEALTHCARE INC. 90478

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death 90341-50(341-130050)91387 (1387-104614)V2.03.05