BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 3222403 · Received July 12, 2013

    Report

    Report Number
    3023361-2013-00041
    Event Type
    Death
    Date Received
    July 12, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 11, 2013
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K050605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS SPACELABS POLICY TO REPORT EACH EVENT ASSOCIATED WITH A PATIENT DEATH.SPACELABS IS EVALUATING THIS EVENT AND WILL FILE A FOLLOW UP REPORT WHEN OUR EVALUATION IS CONCLUDED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT DISCONNECTED THEMSELF FROM THE MONITOR AND SHORTLY AFTER DIED. THE CUSTOMER DOES NOT KNOW IF THE MONITOR ALARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324221 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW MULTIPARAMETER MODULE DSI SPACELABS MEDICAL INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 91496 (1496-009348)