BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS DIGITAL TELEMETRY TRANSMITTER

    MDR report key: 3931249 · Received June 20, 2014

    Report

    Report Number
    3010157426-2014-00004
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    December 24, 2013
    Report Date
    January 23, 2014
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K983996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS FIELD SERVICE ENGINEER (FSE) TESTED THE DEVICE ONSITE AND NO PROBLEM WAS FOUND. THE DEVICE WAS WORKING TO THE SPECIFICATIONS. THE DATA IN THE ICS DATABASE PROVIDED THE CUSTOMER INDICATED THE BELOW: CHEST ELECTRODE (LEAD V1) BECAME DISCONNECTED AT 7:28AM WHICH TRIGGERED THE "LEADS OFF" ALARM. AUTOMATIC LEAD SWITCH FEATURE HAD BEEN TURNED OFF. THIS SHOWN BY THE LEAD ANNOTATION FOR THE STRIP RECORDING AT 7:29 AM WHICH SHOWED "LEAD OFF" FOR LEAD V1 AND THE FACT THAT THE PRIMARY LEAD DID NOT AUTOMATICALLY SWITCH TO LEAD II WHEN THE LEAD V1 CHEST ELECTRODE BECAME DISCONNECTED. AT 7:49 AM, THE PT HAD AN EPISODE OF VENTRICULAR TACHYCARDIA. SUBSEQUENTLY, THE PT'S RHYTHM DEGENERATED INTO V-FIB FOLLOWED BY ASYSTOLE. IN THE TIME PERIOD FROM 7:49 AM TO 8:36 AM, THE MONITOR GENERATED A SERIES OF ALARMS (VENTRICULAR RUN, HIGH HEART RATE, LOW HEART RATE AND ASYSTOLE). AS A RESULT OF THE LOSS OF THE LEAD V1 CHEST ELECTRODE WITH AUTOMATIC LEAD SWITCH FEATURED TURNED OFF, A BLANK WAVEFORM AND THE "LEADS OFF" ALARM WERE DISPLAYED IN THE ECG WAVEFORM ZONE. HOWEVER, THE ECG PROCESSING CONTINUES TO BE PERFORMED USING THE SECOND LEAD. UPON DETECTION OF AN ALARM CONDITION, THE ALARM MESSAGES (I.E. VENTRICULAR RUN ALARM, HIGH RATE ALARM, ETC.) WILL REPLACE THE "LEADS OFF" ALARM IN THE ECG WAVE FORM ZONE FOR THE DURATION OF THE HIGHER PRIORITY ALARMS. TESTING AT SPACELABS ON THE EQUIVALENT DEVICE USING THE WAVEFORM DATA FROM THE PT CONFIRMED THAT ALARM MESSAGES AND FLASHING KEYS ARE PRESENT ON THE MONITOR, EVEN WITH THE PRIMARY ECG LEAD IN A LEADS OFF STATE, AND THAT THESE MESSAGES REPLACE THE "LEADS OFF" MESSAGE. THE ALARM RECORDINGS FROM THE ICS DATABASE CONFIRMED THAT THE DEVICE GENERATED APPROPRIATE ALARMS (SEE POINT 4 ABOVE) DURING THE EVENT. WE HAVE CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION. THIS REPORT IS FINAL AND SPACELABS CONSIDERS THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    NURSES REPORTED THAT A TELEMETRY BED GENERATED "LEADS OFF" ALARM AT THE CENTRAL STATION. MONITOR TECHNICIANS WERE UNABLE TO VIEW THE PT RHYTHM AT THE CENTRAL DISPLAY DURING THE "LEADS OFF" ALARM. DURING THIS ALARM EVENT, THE PT EXPERIENCED A VENTRICULAR FIBRILLATION (V FIB) EVENT, CODED AND DIED. THE MONITOR TECHS WERE UNAWARE THAT THE PT WAS IN V FIB AS THE CENTRAL WAS ONLY ALARMING FOR "LEADS OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364273 SPACELABS DIGITAL TELEMETRY TRANSMITTER MHX: TELEMETRY TRANSMITTER MHX SPACELABS HEALTHCARE INC. 91343

    Patients

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