BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 5956948 · Received September 16, 2016

    Report

    Report Number
    3010157426-2016-00111
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    August 17, 2016
    Report Date
    September 16, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ONSITE TESTING OF THE INVOLVED DEVICES BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THAT ALL EQUIPMENT PERFORMED TO SPECIFICATIONS. TESTING WAS WITNESSED BY A FACILITY STAFF MEMBER. THE FSE ALSO VERIFIED THAT THE DEFAULT (MCM) SETTINGS FOR THE ARTERIAL PRESSURE ALARMS WERE OFF AND HAD NOT BEEN MANUALLY ENABLED BY STAFF UPON INITIATION OF PRESSURE MONITORING. AS A CONSEQUENCE, ALARMS FOR HIGH/LOW PRESSURE CONDITIONS WOULD NOT HAVE BEEN GENERATED. THERE WAS NO MALFUNCTION OF THE DEVICES. THIS INVESTIGATION IS CONSIDERED COMPLETE AND THE ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6), AROUND 7:00 AM, A PATIENT WAS FOUND UNRESPONSIVE AND NO ALARMS OCCURRED AT THE CENTRAL STATION OR BEDSIDE MONITOR NEAR THIS TIME. THE PATIENT WAS RESUSCITATED AND REPORTED TO BE STABILIZED AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606833 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW SL MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 91393/1393-103827 SOFTWARE 3.04.00.