BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL2400 COMPACT MONITOR

    MDR report key: 6046798 · Received October 21, 2016

    Report

    Report Number
    3010157426-2016-00152
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 21, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K102422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED AT SPACELABS¿ EQUIPMENT SERVICE CENTER FOR REPAIR. THE REPORTED PROBLEM WAS VERIFIED. AN INTEGRATED CIRCUIT CHIP, NVRAM (B)(4) 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 REPORT THAT ON (B)(6) 2016 AN ULTRAVIEW COMPACT MONITOR WENT BLANK THEN REBOOTED AND CYCLED DURING PATIENT USE. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697929 SPACELABS ULTRAVIEW SL2400 COMPACT MONITOR 2400 UVSL PATIENT MONITOR MHX SPACELABS HEALTHCARE INC. 91369

    Patients

    Seq Age Sex Outcome Treatment
    1