BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 3922915 · Received June 20, 2014

    Report

    Report Number
    3010157426-2014-00033
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    February 15, 2013
    Report Date
    September 11, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS FILED DUE TO A PT DEATH IDENTIFIED DURING A RETROSPECTIVE REVIEW OF OUR COMPLAINT SYSTEM. THE ISSUE WAS REPORTED IN THE MDR 3010157426-2014-00027. WE HAVE LEARNED ANOTHER PT PASSED AWAY IN THE SAME EVENT USING A DIFFERENT PT MODULE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. HOWEVER, IT IS SPACELABS' POLICY TO SUBMIT A MEDICAL DEVICE REPORT WHENEVER WE BECOME AWARE OF DEATH OF ANY PT CONNECTED TO OUR DEVICES. SPACELABS CONSIDERS THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PT MONITOR DISPLAY BLANKED WHEN A PT CODED. THE PT PASSED AWAY LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362622 SPACELABS ULTRAVIEW SL COMMAND MODULE DSI: ULTRAVIEW MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 9146

    Patients

    Seq Age Sex Outcome Treatment
    1 Death