BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW 1700 MONITOR

    MDR report key: 2799117 · Received October 22, 2012

    Report

    Report Number
    3023361-2012-00042
    Event Type
    Death
    Date Received
    October 22, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 19, 2012
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K972282
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT MONITOR IN USE PRODUCED BOTH VISUAL AND AUDIBLE ALARMS DURING THE EVENT. THE CUSTOMER STATED THAT THE MONITOR STARTED TO PRINT AFTER THEY RESET THE PRINTER MODULE. A SPACELABS' FIELD SERVICE ENGINEER TESTED THE SUBJECT DEVICES ON SITE WITH THE BIOMED. THE DEVICES PASSED ALL TESTS AND WORKED TO SPECIFICATIONS. WE ARE UNABLE TO CONFIRM THE REPORTED SYMPTOM. THE CUSTOMER IS CONTINUING TO USE THE DEVICE TO MONITOR PATIENTS. IT IS SPACELABS' POLICY TO SUBMIT A MEDICAL DEVICE REPORT WHENEVER WE BECOME AWARE OF DEATH OF ANY PATIENT CONNECTED TO OUR DEVICES. WE HAVE CONCLUDED THAT THIS REPORT IS FINAL AND CONSIDER THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT DIED WHEN A SPACELABS PATIENT MONITOR MODEL 90387 WAS IN USE. THE MONITOR PRODUCED ALARMS. THE ISSUE WAS THAT THE MONITOR DID NOT PRINT ALARM STRIPS FROM 9:50AM TO 10:01AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS ULTRAVIEW 1700 MONITOR ULTRAVIEW MULTIPARAMETER MONITOR DSI SPACELABS MEDICAL INC. 90387

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PRINTER MODULE, MODEL 90469