BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW 1700 MONITOR

    MDR report key: 2807393 · Received October 29, 2012

    Report

    Report Number
    3023361-2012-00044
    Event Type
    Death
    Date Received
    October 29, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 28, 2012
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K972282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE MONITOR DID NOT ALARM WHEN A PATIENT DIED AROUND 4:30AM ON (B)(6) 2012. THE CUSTOMER REPORTED THIS EVENT TO SPACELABS ON (B)(6) 2012. DUE TO THE WEEK LONG DELAY IN REPORTING THE MATTER TO SPACELABS, THE PATIENT DATA HAS BEEN REMOVED FROM THE SPACELABS ICS SMART DISCLOSURE DATABASE. OTHER THAN A FEW STRIPS PROVIDED BY THE CUSTOMER, THERE WAS LIMITED PATIENT DATA AVAILABLE TO BE USED IN SPACELABS' INVESTIGATION. BASED ON THE WAVEFORM STRIPS PROVIDED BY THE CUSTOMER, THE MONITOR DID ALARM AND RECORD A STACKED ECG ALARM AT 4:24AM AND A RUN ALARM AT 4:27AM (B)(6) 2012. THE STACKED ECG ALARM APPEARS IF A MONITOR ALARM TRANSITIONS QUICKLY FROM ONE ALARM TYPE TO ANOTHER. IN THIS INSTANCE ONLY ONE ALARM NOTIFICATION SHOWS IN THE THUMBNAILS VIEW AND ANY SUBSEQUENT ALARM CONDITIONS ARE STACKED. IN A STACKED CONDITION, ONLY THE ALARM NOTIFICATION IN THUMBNAILS VIEW IS RECORDED. THERE WERE SEVERAL OTHER ALARMS BEFORE THE EVENT. BECAUSE THE HOSPITAL DID NOT MAINTAIN AND PROVIDE PATIENT WAVEFORM DATA AS OF 4:30AM, WE WERE UNABLE TO CONFIRM ANY ALLEGED FAILURE TO ALARM AT 4:30AM. A SPACELABS' FIELD SERVICE ENGINEER TESTED ALL THE DEVICES INVOLVED IN THE EVENT WITH NO PROBLEM FOUND. THE CUSTOMER IS CONTINUING TO USE THE MONITOR 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 SPACELABS' PATIENT MONITOR MODEL 90387 FAILED TO ALARM WHEN MONITORING A PATIENT. THE PATIENT DIED.

    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 TELEMETRY RECEIVER MODEL 90478, SN (B)(4)| TELEMETRY TRANSMITTER MODEL 90347, SN (B)(4)| RECEIVER HOUSING MODEL 90479-A, SN (B)(4)