BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS XHIBIT CENTRAL STATION

    MDR report key: 6132684 · Received November 29, 2016

    Report

    Report Number
    3010157426-2016-00192
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 4, 2016
    Report Date
    April 26, 2018
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K122146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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 AN INCIDENT WITH DOTTED WAVEFORMS. THE FSE UPDATED THE XHIBIT AND XTR SOFTWARE TO CURRENT VERSION AND THE PROGRAM WAS RESTARTED. THE FIELD SERVICE ENGINEER REPORTS THE XHIBIT IS FUNCTIONING ACCORDING TO SPACELABS¿ SPECIFICATIONS. THIS REPORT IS COMPLETE AND THIS PARTICULAR ISSUE IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON (B)(6) 2016 THAT TELEMETRY WAVEFORMS DISPLAYED AS DOTTED LINES FOR ALL TELEMETRY PATIENTS ON THE XHIBIT CENTRAL STATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784618 SPACELABS XHIBIT CENTRAL STATION S-CLASS CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 96102

    Patients

    Seq Age Sex Outcome Treatment
    1