BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 3941230 · Received July 17, 2014

    Report

    Report Number
    3010157426-2014-00052
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 24, 2014
    Report Date
    April 30, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS IS EVALUATING THIS REPORTED EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN OUR EVALUATION IS CONCLUDED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ONSITE INVESTIGATION OF THE INVOLVED DEVICES BY A SPACELABS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE EQUIPMENT PERFORMED TO SPECIFICATIONS. SPACELABS CLINICAL EDUCATION CONSULTANTS (CEC) WERE ALSO ONSITE TO REVIEW WORKFLOW. IT WAS CONFIRMED THAT THE CUSTOMER DID NOT HAVE THE CENTRAL MONITOR CONFIGURED TO ACCEPT SPO2 ALARMS FOR DISPLAY AT A CENTRAL MONITOR FROM BEDSIDE MONITORS. THE FSE AND CEC WORKED WITH THE CUSTOMER TO CONFIGURE AND IN-SERVICE THE SPO2 ALARM FEATURE FOR CENTRAL MONITORS TO RESOLVE THE CUSTOMER ISSUE. THERE WAS NO EQUIPMENT MALFUNCTION. THIS REPORT IS CONSIDERED COMPLETE AND THE ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT OF FAILURE TO ALARM FOR LOW SPO2 ON THE CENTRAL MONITOR. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT COMMAND MODULE MODEL 91496 DID GENERATE LOW OXYGEN SATURATION (SPO2) ALARMS AT THE BEDSIDE MONITOR; HOWEVER NO ALARM WAS GENERATED AT THE CENTRAL MONITOR ON (B)(6) 2014. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419577 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW SL MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1