BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS DIGITAL TELEMETRY TRANSMITTER

    MDR report key: 4062261 · Received September 4, 2014

    Report

    Report Number
    3010157426-2014-00060
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 6, 2014
    Report Date
    December 19, 2014
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K925510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TELEMETRY TRANSMITTER SENDS PATIENT ECG SIGNALS TO THE TELEMETRY RECEIVER MODULE WHICH CONTAINS THE ECG ALGORITHM FOR PROCESSING THE SIGNALS. THE DATA IS ANALYZED FOR DISPLAY AND ALARM MESSAGING TO A CENTRAL MONITOR. THE CUSTOMER STATED THE TELEMETRY SYSTEM FAILED TO GENERATE AN ALARM FOR A NINE BEAT RUN OF WIDE QRS AT 03:22 A.M. ON (B)(6) 2014. THE CUSTOMER FOUND THIS EVENT WHEN REVIEWING RETROSPECTIVE PATIENT DATA IN THEIR SPACELABS ICS-G2 SYSTEM, WHICH IS A SOFTWARE INTERFACE THAT PROVIDES USER INTERACTION WITH RETROSPECTIVE PATIENT DATA. HAD THE MONITOR ALARMED FOR THIS EVENT, THE EVENT WOULD HAVE REGISTERED IN THE ICS-G2 ALARM HISTORY FOLDER. THERE WAS NO RECORD OF THE EVENT IN THE ALARM HISTORY FOLDER. ONSITE TESTING OF THE INVOLVED DEVICES BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THE EQUIPMENT WORKED TO SPECIFICATIONS. THE TESTING WAS WITNESSED BY A FACILITY STAFF MEMBER. THE ICS DATABASE PROVIDED BY THE CUSTOMER WAS REVIEWED BY A SPACELABS LEAD SOFTWARE ENGINEER. HE CONFIRMED THAT AT 03:22:21 ON (B)(6) 2014 THERE WAS A NINE BEAT RUN OF VENTRICULAR TACHYCARDIA (VTACH) WITH NO ALARM RECORD. THE ECG WAVEFORMS WERE EXTRACTED FROM THE DATABASE AND VIEWED WITH THE EMBEDDED QRS TONE MARKERS VISIBLE ON THE WAVEFORM, SHOWING THAT BEATS 2, 4, 6, AND 8 OF THE 9 BEAT RUN WERE NOT DETECTED BY THE TELEMETRY MODULE. THESE BEATS WERE REJECTED BY THE BEAT QUALIFICATION LOGIC OF THE ECG ALGORITHM AND DETERMINED TO BE T-WAVES DUE TO SUBTLE DIFFERENCES IN TIMING AND SHAPE. THUS, THE VTACH ALARM CRITERIA WITH RESPECT TO RATE AND CONSECUTIVE NUMBER OF VENTRICULAR BEATS WERE NOT MET. THIS SUPPLEMENTAL REPORT IS CONSIDERED FINAL AND THE ISSUE IS CLOSED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SPACELABS IS EVALUATING THIS REPORTED EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN OUR EVALUATION IS CONCLUDED. PLACEHOLDER.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY PATIENT WITH SPACELABS TRANSMITTER MODEL 91343 AND TELEMETRY MODULE MODEL 90478 FAILED TO GENERATE AN ALARM FOR A NINE BEAT RUN OF WIDE QRS. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY PATIENT MONITOR FAILED TO ALARM FOR A 9 BEAT RUN OF WIDE QRS. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542249 SPACELABS DIGITAL TELEMETRY TRANSMITTER TELEMETRY TRANSMITTER MHX SPACELABS HEALTHCARE INC. 91343

    Patients

    Seq Age Sex Outcome Treatment
    1 91343 ((B)(4))| 90478 ((B)(4))