BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS XHIBIT CENTRAL STATION

    MDR report key: 6940104 · Received October 11, 2017

    Report

    Report Number
    3010157426-2017-00089
    Event Type
    Death
    Date Received
    October 11, 2017
    Date of Event
    August 31, 2017
    Report Date
    October 11, 2017
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K122146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS WAS NOTIFIED ABOUT THE EVENT ELEVEN DAYS AFTER THE EVENT. DUE TO THIS DELAY, THE RETROSPECTIVE PATIENT DATA AND ALARM HISTORY WERE NO LONGER AVAILABLE TO INVESTIGATE. THE CUSTOMER WAS ALSO UNABLE TO LOCATE ANY WAVEFORM RECORDINGS OF THE COMPLAINT EPISODE. ONSITE TESTING BY A SPACELABS FIELD SERVICE ENGINEER FOR THE INVOLVED DEVICES CONFIRM THAT ALL DEVICES PERFORM TO SPECIFICATION. THE CUSTOMER CONTINUED TO USE THE INVOLVED DEVICES, CONSEQUENTLY THE PATIENT SETTINGS HAD BEEN CHANGED. BASED UPON THE CUSTOMER¿S STATEMENT THAT ALARM NOTIFICATIONS WERE PRESENT AT THE BEDSIDE MONITOR, THEREFORE APPROPRIATELY CLASSIFIED, WE KNOW OF NO REASON THAT AUDIBLE AND VISUAL ALARM INDICATORS WOULD NOT HAVE BEEN PRESENT AT THE CENTRAL MONITOR AS ALARM INDICATORS FOR THE BEDSIDE AND CENTRAL MONITOR OPERATED ACCORDING TO SPECIFICATIONS WHEN TESTED BY A SPACELABS FIELD SERVICE ENGINEER. THIS REPORT IS CONSIDERED COMPLETE AND THE MATTER CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2017, A PATIENT WENT INTO AN ASYSTOLE RHYTHM AND THE CENTRAL MONITOR DID NOT ALARM. IT WAS CONFIRMED THAT THE PATIENT¿S BEDSIDE MONITOR DID ALARM DURING THE EVENT. THE PATIENT OUTCOME ASSOCIATED TO THE EVENT WAS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722294 SPACELABS XHIBIT CENTRAL STATION XHIBIT CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 96102

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 91387-27 (1387-104655)91496 (1496-102324)