BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3155 INFO CNTR NETWORK DB REL N. O

    MDR report key: 4192702 · Received October 10, 2014

    Report

    Report Number
    1218950-2014-06030
    Event Type
    Death
    Date Received
    October 10, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT EXPIRED AFTER BEING DISCOVERED AT 6:15 AM WHEN MONITORING HAD STOPPED AT 4:56 AM. THE CUSTOMER REQUESTED INFO REGARDING WHETHER OR NOT ALARMS WERE PROVIDED AT CENTRAL AS STAFF WERE NOT AWARE OF ANY BUT BELIEVED THAT PT MAY HAVE PULLED HIS LEADS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643261 M3155 INFO CNTR NETWORK DB REL N. O MHX PHILIPS MEDICAL SYSTEMS 865418

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death