BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER CLIENT

    MDR report key: 1746165 · Received June 30, 2010

    Report

    Report Number
    1218950-2010-01054
    Event Type
    Death
    Date Received
    June 30, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 24, 2010
    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

    THE CUSTOMER REPORTED THAT THE PATIENT LEADS MAY HAVE COME OFF AND A PATIENT DEATH OCCURRED. BASED UPON PRELIMINARY INFORMATION AND INTERVIEWS WITH A PHILIPS FIELD SERVICE ENGINEER (FSE) WHO SPOKE WITH THE CUSTOMER, THE CUSTOMER BELIEVES THAT THE PATIENT LEADS MAY HAVE COME OFF DURING THE NIGHT AND STAYED OFF FOR UP TO 4 HOURS. WE WILL CONSIDER THAT THE DEVICE WAS A FACTOR AS STAFF WAS NOT IMMEDIATELY AWARE OF OR RESPONSIVE TO THE NEEDS OF THE PATIENT. THE PATIENT EXPIRED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT LEADS MAY HAVE COME OFF AND A PATIENT DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE INFORMATION CENTER CLIENT MHX PHILIPS MEDICAL SYSTEMS 865094 (M3155)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death