BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS DIGITAL TELEMETRY TRANSMITTER

    MDR report key: 4712743 · Received April 21, 2015

    Report

    Report Number
    3010157426-2015-00044
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    March 27, 2015
    Report Date
    June 9, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K983996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DECLINED ON SITE TESTING OF THE INVOLVED DEVICES BY A SPACELABS FIELD SERVICE ENGINEER SINCE THE INVOLVED EQUIPMENT WAS IN USE ON ANOTHER PATIENT WITHOUT ISSUE. SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    USING THE PATIENT RETROSPECTIVE DATABASE PROVIDED BY THE CUSTOMER, WE OBSERVED THE FOLLOWING: LEADS I AND II WERE THE MONITORED LEADS AT THE TIME OF THE COMPLAINT EVENT. THE QRS AMPLITUDE IN BOTH LEADS WAS VERY LOW (ABOUT 0.20 MV). AT THE TIME OF THE SPECIFIED EVENT, THERE WAS AN EIGHT BEAT EPISODE OF VENTRICULAR TACHYCARDIA. THERE WAS NO CORRESPONDING ALARM RECORD IN THE DATABASE. WE EXTRACTED THE PATIENT¿S ECG WAVEFORMS FROM THE DATABASE TO EXAMINE THE DETECTION MARKERS EMBEDDED IN THE WAVEFORM DATA AT THE TIME OF THE ORIGINAL ANALYSIS FOR FURTHER REVIEW. FROM THESE MARKERS, WE DETERMINED THAT ALL BEATS IN THE EVENT HAD BEEN DETECTED. WHEN WE EXAMINED THE BEAT CLASSIFICATIONS, WE NOTED THAT NOT ALL BEATS IN THE EVENT HAD BEEN CLASSIFIED AS VENTRICULAR. CLASSIFICATION IS ESPECIALLY PROBLEMATIC IN THE PRESENCE OF LOW AMPLITUDE WAVEFORMS SINCE THE AMPLITUDE DIFFERENCES BETWEEN NORMAL AND VENTRICULAR BEATS BECOMES INDETERMINATE FOR CLASSIFICATION ANALYSIS. ADDITIONALLY, ECG COMPLEX WIDTH IS A LESS RELIABLE METRIC WITH LOW AMPLITUDE WAVEFORM. THIS RESULTED IN SOME OF THE EVENT BEATS CLASSIFIED AS NORMAL AND NOT VENTRICULAR. THIS REPORT IS CONSIDERED COMPLETE AND THE ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY PATIENT MONITORED WITH TRANSMITTER MODEL 90343-5, RECEIVER MODULE MODEL 90478 AND CENTRAL MONITOR MODEL 91387-38 EXPERIENCED A SEVEN BEAT RUN OF VENTRICULAR TACHYCARDIA WITH A HEART RATE OF 141 BEATS PER MINUTE ON (B)(6) 2015 WHICH DID NOT GENERATE AN ALARM. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262468 SPACELABS DIGITAL TELEMETRY TRANSMITTER TELEMETRY TRANSMITTER MPT MHX SPACELABS HEALTHCARE INC. 90343

    Patients

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