BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW PATIENT MONITOR

    MDR report key: 6200667 · Received December 22, 2016

    Report

    Report Number
    3010157426-2016-00204
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 22, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K102422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWELVE YEAR OLD DEVICE WAS SENT TO SPACELABS HEALTHCARE FOR FURTHER ANALYSIS, AND THE REPORTED PROBLEM WAS VERIFIED. THE NVRAM AND POWER SWITCH WERE REPLACED, THE REPAIRED UNIT PASSED ALL FUNCTIONAL TESTS, AND WAS RETURNED TO THE CUSTOMER FOR SERVICE. THIS REPORT IS COMPLETE AND THIS PARTICULAR ISSUE IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT THE BEDSIDE MONITOR HAD ¿NO POWER¿ ON (B)(6), 2016 DURING PATIENT USE. THE PATIENT WAS PLACED ON A PORTABLE MONITOR TO CONTINUE MONITORING. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849472 SPACELABS ULTRAVIEW PATIENT MONITOR MULTIPARAMETER PATIENT MONITOR MHX SPACELABS HEALTHCARE INC. 91387

    Patients

    Seq Age Sex Outcome Treatment
    1