BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP30 INTELLIVUE PT MONITOR

    MDR report key: 3863034 · Received June 5, 2014

    Report

    Report Number
    9610816-2014-00160
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEM
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT WAS FOUND WITH THE ECG LEADS OFF. THE USER REATTACHED THE ECG LEADS AND STARTED RESUSCITATION. THE PT DIED. THE USER STATED THAT THERE WAS NO AUDIBLE ECG LEADS OFF ALARM, BUT THAT DID NOT CONTRIBUTE TO THE PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328866 MP30 INTELLIVUE PT MONITOR MHX PHILIPS MEDICAL SYSTEM M8002A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death