BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP20 INTELLIVUE PATIENT MONITOR

    MDR report key: 1841165 · Received September 15, 2010

    Report

    Report Number
    9610816-2010-00478
    Event Type
    Death
    Date Received
    September 15, 2010
    Date of Event
    November 1, 2009
    Report Date
    September 9, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT FOLLOWING A DEATH A YEAR AGO, THE CUSTOMER WAS SEEKING ASSISTANCE FROM PHILIPS REGARDING A LEGAL MATTER WHERE PHILIPS REQUIREMENT IS NOT IMPLICATED. THE AVAILABLE INFO DOES NOT SUPPORT THAT PHILIPS EQUIPMENT WAS A FACTOR IN THE PT'S DEATH, THE CUSTOMER REQUESTED A PHILIPS FIELD SERVICE ENGINEER TO CHECK THE MONITOR FUNCTIONALITY. THIS IS BEING REPORTED ONLY BECAUSE A PHILIPS DEVICE WAS IN USE ON A PT WHO DIED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A DEATH A YEAR AGO, THE CUSTOMER WAS SEEKING ASSISTANCE FROM PHILIPS REGARDING A LEGAL MATTER WHERE PHILIPS REQUIREMENT IS NOT IMPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP20 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8001A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death