BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS XHIBIT CENTRAL STATION

    MDR report key: 7438738 · Received April 17, 2018

    Report

    Report Number
    3010157426-2018-00066
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    March 26, 2018
    Report Date
    May 10, 2018
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K122146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION AND WILL FILE A SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE SPACELABS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE FOR FURTHER ANALYSIS OF THE REPORTED ISSUE. INVESTIGATIVE FINDINGS DETERMINED THE XHIBIT CENTRAL STATION EXPERIENCED PERFORMANCE ISSUES. THE XHIBIT CENTRAL STATION WAS RESTARTED. THE FIELD SERVICE ENGINEER REPORTS THE XHIBIT CENTRAL STATION IS FUNCTIONING ACCORDING TO SPACELABS¿ SPECIFICATIONS. THIS REPORT IS COMPLETE AND THIS PARTICULAR ISSUE IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON (B)(6) 2018 THAT THE XHIBIT CENTRAL STATION DEVELOPED DISPLAY ISSUES RESULTING IN A LOSS OF MONITORING FOR 40 TELEMETRY PATIENTS. NO INJURY WAS REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281077 SPACELABS XHIBIT CENTRAL STATION XHIBIT CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 96102

    Patients

    Seq Age Sex Outcome Treatment
    1