BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW COMMAND MODULE

    MDR report key: 6122958 · Received November 22, 2016

    Report

    Report Number
    3010157426-2016-00182
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    October 23, 2016
    Report Date
    December 29, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WAVEFORM FILE RETRIEVED FROM THE SITE WAS REVIEWED BY A SPACELABS LEAD SOFTWARE ENGINEER WHO VERIFIED THAT THE MONITOR DID DETECT AND REPORT A HEART RATE OF ¿0¿. THE 90496 COMMAND MODULE ONLY REPORTS A HR OF ZERO WHEN IT DETECTS VENTRICULAR FIBRILLATION OR ASYSTOLE. THERE IS NO ALARM INFORMATION IN THE RETRIEVED DATABASE FOR THE EMERGENCY DEPARTMENT UNIT, SO THE ALARM PERFORMANCE OF THE MODULE DURING THE ASYSTOLE CANNOT BE DIRECTLY EVALUATED. THE DEVICE DID PERFORM TO SPECIFICATION; THE 90496 COMMAND MODULE DETECTED A LACK OF CARDIAC ACTIVITY AND REPORTED A HEART RATE OF ZERO. BY DESIGN, THIS WILL RESULT IN AN ASYSTOLE ALARM. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE IS CLOSED.

    Additional Manufacturer Narrative · 1

    THE BEDSIDE MONITOR WAS REMOVED FROM THE DEPARTMENT AND SEQUESTERED FOR TESTING BY A SPACELABS FIELD SERVICE ENGINEER. ONSITE TESTING BY THE FSE OF THE THIRTEEN AND FOURTEEN YEAR OLD DEVICES, SHOWED FINDINGS OF A LOW AUDIO VOLUME SETTING ON THE BEDSIDE MONITOR AS WELL AS CHANGES WITHIN THE DEFAULT ECG SETTINGS. TESTING OF THE CENTRAL MONITOR SHOWED AN ADMIT/DISCHARGE MENU OVERLAID ON NORMAL MENUS,AND THE SYSTEM WAS RESET TO CORRECT THE DISPLAY. THE INVOLVED DEVICES ALARMED APPROPRIATELY WHEN TESTED WITH A SIMULATED ASYSTOLE CONDITION. THE PATIENT'S HISTORICAL WAVEFORMS AND TREND INFORMATION WAS SENT TO SPACELABS FOR ANALYSIS. SPACELABS WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2016 AT 10:24 A.M. BOTH THE BEDSIDE AND CENTRAL MONITOR DID NOT ALARM WHEN A PATIENT¿S HEART RHYTHM CHANGED TO ASYSTOLE. THE HOSPITAL REPORTED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771471 SPACELABS ULTRAVIEW COMMAND MODULE ULTRAVIEW MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 90496

    Patients

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