BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFORMATION CENTER NETWORK DATABASE

    MDR report key: 1736082 · Received June 22, 2010

    Report

    Report Number
    1218950-2010-00963
    Event Type
    Death
    Date Received
    June 22, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 10, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A PATIENT DEATH OCCURRED, HOWEVER, NO PT DATA WAS SAVED PRIOR TO DISCHARGE ON THE INFO CENTER NETWORK DEVICE. THIS IS BEING REPORTED ONLY BECAUSE A PHILIPS DEVICE WAS IN USE ON A PATIENT WHO HAD EXPIRED. PRELIMINARY INVESTIGATION SHOWS MANY ALARMS FOR THIS PATIENT WITH ALARM LOG RECORDS AND OTHER INDICATIONS OF ACKNOWLEDGEMENT OF THE ALARMS. THERE IS NO ALLEGATION OR INDICATION OF ANY DEVICE MALFUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO 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 A PATIENT DEATH OCCURRED, HOWEVER NO PATIENT DATA WAS SAVED PRIOR TO DISCHARGE ON THE INFO CENTER NETWORK DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFORMATION CENTER NETWORK DATABASE MHX, DRT MHX PHILIPS MEDICAL SYSTEMS 865011 (M3155)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death