BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 4714069 · Received April 21, 2015

    Report

    Report Number
    3010157426-2015-00047
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    March 30, 2015
    Report Date
    June 14, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICES WERE RETURNED TO SPACELABS FOR INVESTIGATION BY A PRODUCT SUPPORT SPECIALIST. COMMAND MODULE LOGS CONFIRMED THAT MULTIPLE RESETS HAD OCCURRED ON THE MODULE. THE MONITOR HAD NOT LOGGED ANY RESETS. THE MODULE RESETS EXPERIENCED BY THE CUSTOMER WERE TRIGGERED BY A SOFTWARE MEMORY ACCESS ERROR SPECIFIC TO MODULES WITH THE MASIMO PCBA PART NUMBER 010-1136-02 FOR OXYGEN SATURATION MEASUREMENT. ROOT CAUSE WAS DETERMINED TO BE A CHANGE IN THE FIRMWARE VERSION NUMBER COMMUNICATED BY THE MASIMO PCBA WHICH WAS NOT APPROPRIATELY PROCESSED BY THE MODULE RESIDENT SOFTWARE. THE MODULE¿S MEMORY ARRAY SET UP TO HOLD THE FULL VERSION STRING WAS NOT SIZED TO HANDLE THE COMPLETE RANGE OF NUMBERS SENT BY THE MASIMO PCBA. THE RESULT OF THE ARRAY OVERFLOW WAS A MODULE RESET. A COMPATIBLE SOFTWARE VERSION FOR THE COMMAND MODULE WAS PROVIDED WHICH RESOLVED THIS ISSUE. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE IS CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2014 COMMAND MODULE MODEL 91496 (SN (B)(4)) EXPERIENCE SEVERAL RESETS WHICH FROZE THE MASIMO OXYGEN SATURATION PARAMETER ON THE QUBE BEDSIDE MONITOR MODEL 91390 BEFORE THE SYSTEM COMPLETELY STOPPED WORKING. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265187 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW SL MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1