BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS XHIBIT CENTRAL STATION

    MDR report key: 5430837 · Received February 11, 2016

    Report

    Report Number
    3010157426-2016-00013
    Event Type
    Malfunction
    Date Received
    February 11, 2016
    Date of Event
    January 11, 2016
    Report Date
    April 14, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K050742
    Removal / Correction Number
    RES73634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENT REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE ISSUE HAS BEEN TRACED TO THE TEXAS INSTRUMENT (TI) MSP430 MICROCONTROLLER USED ON THE MODEL 96280 TELEMETRY RECEIVER QUAD RECEIVER CARD (QRC) PCBA THAT HAS AN INTERNAL HARDWARE DEFECT THAT AFFECTS THE PROPER CLOCKING OF DIGITAL DATA COMMUNICATIONS ON SOME QRC UNITS. THE PRESENCE OF AN ¿XTR OFFLINE¿ MESSAGE REFLECTS AN EXTREMELY HIGH NUMBER OF THE DIGITAL DATA INTERRUPTIONS RAPIDLY OCCURRING. IN ORDER TO CORRECT THIS ISSUE, A NEW VERSION OF THE TI MSP430 IS BEING IMPLEMENTED THAT INCLUDES A HARDWARE CORRECTION FOR THE CLOCKING DEFECT. SPACELABS CONSIDERS THIS MEDWATCH CLOSED. FURTHER ACTIONS AND INFORMATION WILL BE DOCUMENTED UNDER THE SPACELABS FIELD CORRECTIVE ACTION PROCESS.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2016 FOUR TELEMETRY BEDS WENT OFFLINE FROM THE XHIBIT CENTRAL MONITOR MODEL 96102. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT. THIS CONDITION WAS QUICKLY REMEDIED BY RESETTING THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90000 SPACELABS XHIBIT CENTRAL STATION S-CLASS CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 96102

    Patients

    Seq Age Sex Outcome Treatment
    1