BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL2400 COMPACT MONITOR

    MDR report key: 4974122 · Received August 5, 2015

    Report

    Report Number
    3010157426-2015-00153
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 7, 2015
    Report Date
    September 23, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K102422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED AT SPACELABS¿ EQUIPMENT SERVICE CENTER FOR REPAIR. THE REPORTED PROBLEM WAS VERIFIED. THE INTEGRATED CHIP NOVRAM DS1646 COMPONENT WAS NOT FUNCTIONING; THEREFORE, THE COMPONENT WAS REPLACED. THE REPAIRED UNIT PASSED ALL FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER. LACK OF A DISPLAY WAS THE WARNING SIGN THAT THE CUSTOMER NOTICED AND THAT PROMPTED THE ACTION OF REMOVING THE PRODUCT FROM USE. THIS REPORT IS COMPLETE AND THIS PARTICULAR ISSUE IS CONSIDERED CLOSED. SPACELABS MONITORS ITS COMPLAINTS FOR SIMILAR PRODUCT ISSUES TO DETERMINE NEED FOR ADDITIONAL INVESTIGATION.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A SERVICE REPAIR REQUEST FOR INTERMITTENT DISPLAY AND REBOOT FOR BEDSIDE MONITOR MODEL 91369 WHILE IN USE ON (B)(6) 2015. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517171 SPACELABS ULTRAVIEW SL2400 COMPACT MONITOR 2400 UVSL PATIENT MONITOR MHX SPACELABS HEALTHCARE INC. 91369

    Patients

    Seq Age Sex Outcome Treatment
    1