BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW PATIENT MONITOR

    MDR report key: 3922914 · Received June 20, 2014

    Report

    Report Number
    3010157426-2014-00014
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    October 3, 2013
    Report Date
    March 2, 2014
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K102422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SPACELABS FIELD SERVICE ENGINEER (FSE) TESTED ALL THE INVOLVED DEVICES ONSITE WITH NO PROBLEM FOUND. ALL THE DEVICES WERE FUNCTIONING TO SPECIFICATIONS. FULL DISCLOSURE DATA INDICATES THAT THE CENTRAL MONITOR DID ALARM AND THE ALARM WAS RECORDED IN THE SYSTEM. THE CUSTOMER STATED THAT THERE WAS NO DEVICE MALFUNCTION DURING THE EVENT. IT IS SPACELABS' POLICY TO SUBMIT AN MDR WHEN WE BECOME AWARE OF DEATH OF ANY PATIENT CONNECTED TO OUR DEVICES. WE HAVE CONCLUDED THAT THIS REPORT IS FINAL AND CONSIDER THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A CENTRAL MONITOR DID NOT ALARM ON VFIB AT 20:42. THE PT PASSED AWAY AT 21:17. CLINICAL ACCESS DOES HAVE THE ALARM STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362528 SPACELABS ULTRAVIEW PATIENT MONITOR MHX: MULTIPARAMETER PATIENT MONITOR MHX SPACELABS HEALTHCARE INC. 91387

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 90478, S/N (B)(4)| 90479, S/N (B)(4)| 96281, S/N (B)(4)