BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS XHIBIT CENTRAL STATION

    MDR report key: 6202516 · Received December 23, 2016

    Report

    Report Number
    3010157426-2016-00206
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    November 27, 2016
    Report Date
    January 31, 2017
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K122146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AT SPACELABS FOR DEPOT REPAIR, AND THE REPORTED PROBLEM WAS NOT REPRODUCIBLE. THE DEVICE WAS TESTED IN ACCORDANCE WITH ALL RELEVANT PROCEDURES. NORMAL DEVICE OPERATION WAS VERIFIED AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    SPACELABS TECHNICAL SUPPORT GUIDED THE CUSTOMER ON PERFORMING A HARD SHUTDOWN AND RESTART TO RESUME TELEMETRY MONITORING. A LOANER DEVICE WAS PUT IN PLACE WHILE THE CENTRAL STATION WAS SENT IN FOR REPAIR. 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 THAT ON (B)(6) 2016, A BLUE SCREEN WAS DISPLAYING ON THE XHIBIT CENTRAL STATION AND A LOSS OF TELEMETRY MONITORING OCCURRED. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852845 SPACELABS XHIBIT CENTRAL STATION S-CLASS CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 96102

    Patients

    Seq Age Sex Outcome Treatment
    1