BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS XPREZZON BEDSIDE MONITOR

    MDR report key: 6167790 · Received December 12, 2016

    Report

    Report Number
    3010157426-2016-00194
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 12, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K112962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED AT SPACELABS¿ EQUIPMENT SERVICE CENTER FOR REPAIR. THE REPORTED PROBLEM WAS VERIFIED , AND THE POWER SUPPLY PCBA AND NOVRAM WERE REPLACED. THE REPAIRED UNIT PASSED ALL FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER. THIS REPORT IS COMPLETE AND THIS PARTICULAR ISSUE IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A COMPLAINT THAT BEDSIDE MONITOR DISPLAYED A GREEN SCREEN AND INTERMITTENTLY SHUT OFF LASTING MORE THAN A MINUTE WHILE IN USE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819049 SPACELABS XPREZZON BEDSIDE MONITOR S-CLASS MULTIPARAMETER PATIENT MONITOR MHX SPACELABS HEALTHCARE INC. 91393

    Patients

    Seq Age Sex Outcome Treatment
    1