BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 3211596 · Received July 8, 2013

    Report

    Report Number
    3023361-2013-00039
    Event Type
    Death
    Date Received
    July 8, 2013
    Date of Event
    May 27, 2013
    Report Date
    July 8, 2013
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K050605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS SPACELABS POLICY TO REPORT EVERY EVENT THAT INVOLVES 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 MEDIUM PRIORITY ALARM COVERED A HIGH PRIORITY ALARM FOR ASYSTOLE AND THE HIGH PRIORITY ALARM NEVER WENT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311715 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW MULTIPARAMETER MODULE DSI SPACELABS MEDICAL INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 91496 (NA)