BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER

    MDR report key: 1771729 · Received July 22, 2010

    Report

    Report Number
    1218950-2010-01175
    Event Type
    Death
    Date Received
    July 22, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 16, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K062271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALLEGED THAT THERE WAS A FAILURE OF THE MONITOR TO ALARM FOR A VTACH EVENT. THE PT EXPIRED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT 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 ALLEGED THAT THERE WAS A FAILURE OF THE MONITOR TO ALARM FOR A VTACH EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE INFORMATION CENTER MHX PHILIPS MEDICAL SYSTEMS 862124 (M3150B)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death