BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP90 INTELLIVUE PATIENT MONITOR

    MDR report key: 1739009 · Received June 24, 2010

    Report

    Report Number
    9610816-2010-00217
    Event Type
    Death
    Date Received
    June 24, 2010
    Date of Event
    May 21, 2010
    Report Date
    June 21, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED PHILIPS SEEKING INFORMATION AND DATA RETENTION FOR A PATIENT WHO HAD EXPIRED. THIS IS BEING REPORTED ONLY BECAUSE A PHILIPS DEVICE WAS IN USE ON A PATIENT WHO DIED. THERE IS NO ALLEGATION OR INDICATION OF A MALFUNCTION OF THE DEVICE. THERE IS NO ALLEGATION OR INDICATION THAT THIS DEVICE WAS A FACTOR IN THE DEATH. 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 CONTACTED PHILIPS SEEKING INFORMATION AND DATA RETENTION FOR A PATIENT WHO HAD EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP90 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8010A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death