BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ELANCE VITAL SIGNS MONITOR

    MDR report key: 3931242 · Received June 20, 2014

    Report

    Report Number
    3010157426-2013-00014
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    November 11, 2013
    Report Date
    January 21, 2014
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K093501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER LEFT THE NIBP CUFF ON THE PT AND LEFT THE NIBP PRODUCT ON AUTO MEASUREMENT AFTER THE PT DIED. NIBP READINGS WILL RESULT FROM MUSCLE CONTRACTION OCCURRING AFTER A DEATH. SPACELABS FIELD SERVICE ENGINEER (FSE) TESTED THE DEVICE IN THE FIELD IN ACCORDANCE WITH THE TEST PROCEDURES IN THE SERVICE MANUAL. THE DEVICE PASSED ALL TESTS AND NO PROBLEM WAS FOUND. THE CUSTOMER HAS BEEN NOTIFIED AND ACCEPTED THE CLINICAL EXPLANTATION THAT THE NIBP READING SHOWN ON THE DEAD PT WAS DUE TO MUSCLE CONTRACTION AFTER THE PT DIED. THE CUSTOMER IS CONTINUING TO USE THE DEVICE TO MONITOR PATIENTS AND NO FURTHER ISSUES WERE RECEIVED. IT IS SPACELABS' POLICY TO SUBMIT AN MDR WHEN WE BECOME AWARE OF DEATH OF ANY PT CONNECTED TO OUR DEVICES. WE HAVE CONCLUDED THAT HE DEVICE DID NOT MALFUNCTION. THE DEVICE DID NOT CONTRIBUTE TO PT'S DEATH. THIS REPORT IS FINAL AND SPACELABS CONSIDERS THIS ISSUE IS CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT AN ELANCE MONITOR MODEL 93300 SHOWED NIBP READINGS ON A DEAD PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364339 SPACELABS ELANCE VITAL SIGNS MONITOR MHX: MULTIPARAMETER PT MONITOR MHX SPACELABS HEALTHCARE INC. 93300

    Patients

    Seq Age Sex Outcome Treatment
    1 Death