BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS XHIBIT CENTRAL STATION

    MDR report key: 6037503 · Received October 18, 2016

    Report

    Report Number
    3010157426-2016-00151
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 26, 2016
    Report Date
    December 1, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K122146
    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 SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    PATIENT MONITORING RESUMED BY DISCONNECTING THE NETWORK CABLE, REBOOTING THE CENTRAL MONITOR, THEN READMITTING THE TELEMETRY PATIENTS TO THE DEVICE. ONSITE INVESTIGATION BY A SPACELABS FIELD SERVICE ENGINEER (FSE) FOUND THAT THE PROBLEM HAD RESOLVED, AND COULD NOT BE REPRODUCED. THERE HAVE BEEN NO FURTHER REPORTS OF RECURRENCE FOR THE PAST TWO MONTHS. THIS INVESTIGATION IS CONSIDERED COMPLETE AND THE ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2016 THE XHIBIT CENTRAL STATION KEPT REBOOTING. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687832 SPACELABS XHIBIT CENTRAL STATION S-CLASS CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 96102

    Patients

    Seq Age Sex Outcome Treatment
    1