BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 3183195 · Received June 21, 2013

    Report

    Report Number
    3023361-2013-00037
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    April 7, 2014
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS IS EVALUATING THIS EVENT AND WILL FILE A FOLLOW UP REPORT WHEN OUR EVALUATION IS CONCLUDED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED PATIENT WAVEFORM DATA FOR OUR REVIEW. WE NOTED THAT OF THE 18 EPISODES OF VRUN PROVIDED, ONLY 14 EPISODES MET THE FIVE BEATS REQUIREMENT FOR VRUN ALARM. A REVIEW OF THE PRODUCT'S FULL DISCLOSURE DATABASE SHOWS NINE OF THE 14 EPISODES DID ALARM. FIVE OF THE 14 EPISODES DID NOT ALARM DUE TO LOW-LEVEL ARTIFACT OR NOISE THAT COMPROMISED SIGNAL QUALITY, CAUSING THE BEAT DETECTOR TO PAUSE AS DESIGNED UNTIL SIGNAL QUALITY IMPROVED. THE ANALYSIS OF THE PRODUCT SHOWED THAT IT WAS OPERATING TO SPECIFICATIONS. THERE HAVE BEEN NO FURTHER REPORTS CONCERNING THIS DEVICE AND SPACELABS CONSIDERS THIS ISSUE CLOSED. PLACEHOLDER.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT OF FAILURE TO ALARM FOR VRUN.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT OF FAILURE TO ALARM FOR VRUN. THE CUSTOMER IDENTIFIED 18 EPISODES OF VRUN, BUT ONLY SIX ALARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283020 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT MONITOR, MODEL 91393, V3.00.07| 91496 (NOT AVAILABLE)