BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW PATIENT MONITOR

    MDR report key: 3922903 · Received June 20, 2014

    Report

    Report Number
    3010157426-2014-00010
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    January 24, 2013
    Report Date
    February 24, 2014
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K102422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVENT, THE PATIENT WAS MONITORED BY SPACELABS TELEMETRY SYSTEM AND CENTRAL MONITOR. THE HOSPITAL CONFIRMED THAT THERE WAS NO DEVICE FAILURE. THE DEVICES DID GENERATE ALARMS DURING THE EVENT. THE HOSPITAL CONFIRMED THAT THE NURSE ACKNOWLEDGED BEFORE, DURING AND AFTER PAGES. ALL THE INVOLVED DEVICES WERE TESTED BY A SPACELABS' FIELD SERVICE ENGINEER (FSE) IN THE HOSPITAL WITH NO PROBLEM FOUND. THE DEVICES RETURNED TO SERVICE AFTER TESTING AND CONTINUE TO MONITOR PATIENTS. 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 HOSPITAL NURSE DID NOT RECEIVE ANY NOTIFICATION THROUGH HER NURSE PHONE. AS A RESULT, THE NURSE WAS NOT AWARE OF A PATIENT'S CONDITION. THE PATIENT PASSED AWAY AFTER THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362573 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)| 91343, S/N (B)(4)