BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER CLIENT

    MDR report key: 2221325 · Received August 19, 2011

    Report

    Report Number
    1218950-2011-02449
    Event Type
    Death
    Date Received
    August 19, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 12, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED AND IT WAS UNCLEAR IF ALARMS OCCURRED OR WERE HEARD AT THE CENTRAL STATION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED AND IT WAS UNCLEAR IF ALARMS OCCURRED OR WERE HEARD AT THE CENTRAL STATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death