BEUDAMED
    FDA Adverse Event Death Summary report: N

    DASH 3000

    MDR report key: 1021148 · Received March 27, 2008

    Report

    Report Number
    2124823-2008-00041
    Event Type
    Death
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 27, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K073462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION TEAM REVIEWED THE CIC LOGS AND THE INVESTIGATION REVEALED THAT AN ASYSTOLE ALARM WAS CALLED AT 9:01:39 AM WHICH TRIGGERED A CRISIS ALARM. THE ALARM VOLUME WAS 70% AT THE CIC IN THE NURSING UNIT AND 10% AT THE CIC IN THE MONITOR TECH ROOM. AN ASYSTOLE ALARM WAS CALLED AGAIN AT 9:03:17 AM WHICH AGAIN TRIGGERED A CRISIS ALARM. THE CIC WAS THEN SILENCED AND THE DASH MONITOR WAS PLACED IN ALARM PAUSE AT 9:03:19 AM. THUS THE INVESTIGATION RESULT CONCLUDED THAT THE SYSTEM ALARMED AT THE TIME OF THE EVENT AND THE DEVICE PERFORMED AS PER SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THEIR DASH MONITOR FAILED TO ALARM FOR ASYSTOLE. THERE WAS A PT DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH 3000 PATIENT MONITOR MHX GE HEALTHCARE 420000-001

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death