BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 5053260 · Received September 3, 2015

    Report

    Report Number
    3010157426-2015-00171
    Event Type
    Death
    Date Received
    September 3, 2015
    Date of Event
    August 18, 2015
    Report Date
    October 6, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONSITE TESTING OF THE INVOLVED DEVICES BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THE EQUIPMENT PERFORMED TO SPECIFICATIONS. IT WAS ALSO NOTED THAT THIS WAS A PACED PATIENT AND PACEMAKER DETECTION WAS TURNED OFF. A COPY OF THE PATIENT RETROSPECTIVE DATABASE WAS PROVIDED BY THE CUSTOMER FOR FURTHER ANALYSIS. SPACELABS HAS LAUNCHED AN INVESTIGATION IN THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED PATIENT RETROSPECTIVE DATABASE WAS REVIEWED BY A SPACELABS LEAD SOFTWARE ENGINEER. AT THE BEGINNING OF THE RECORD THE CUSTOMER ENABLED AND DISABLED PACEMAKER DETECTION MULTIPLE TIMES. THERE ARE ALSO MANY ONGOING ARTIFACT PROBLEMS DUE TO ECG ELECTRODE TO SKIN CONNECTIONS. AT 11:45 P.M. ON (B)(6) 2015 THE PATIENT ENTERED A PERIOD OF VENTRICULAR ARRHYTHMIA AS IDENTIFIED IN THE DATABASE AND WITH AN ASSOCIATED VRUN ALARM. THE CUSTOMER CHOSE TO OVERRIDE THE HIGH ALARM PRIORITY ALARM SETTING FOR THIS ARRHYTHMIA AND RESET IT TO MEDIUM PRIORITY; HIGH AND LOW HEART RATE ALARMS WERE ALSO SET TO MEDIUM PRIORITY. THERE WERE MULTIPLE ALARMS OF THESE TYPES IN THE ALARM LOG BEGINNING AT THIS TIME. HOWEVER, THE ALARM THRESHOLD FOR VENTRICULAR FIBRILLATION WAS NOT MET SINCE THE VENTRICULAR BEATS WERE TOO WELL ORGANIZED FOR FREQUENCY AND SHAPE. THERE WAS NO MALFUNCTION. THE DEVICE WORKED AS DESIGNED AND WITH RESPECT TO THE CUSTOMER SELECTED ALARM PRIORITY. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE IS CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A XPREZZON BEDSIDE MONITOR, MODEL 91393 WITH COMMAND MODULE MODEL 91496, FAILED TO ALARM FOR VENTRICULAR FIBRILLATION ON (B)(6) 2015. THE PATIENT PASSED AWAY SUBSEQUENT TO THIS EVENT. THE CUSTOMER WAITED UNTIL (B)(6) 2015 TO REPORT THIS EVENT TO SPACELABS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584128 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW SL MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 Death