BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MP5

    MDR report key: 2172070 · Received July 18, 2011

    Report

    Report Number
    9610816-2011-00381
    Event Type
    Death
    Date Received
    July 18, 2011
    Report Date
    June 29, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K091395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE MP5 MONITOR WAS GIVING A "LEADS OFF" INOP MESSAGE, WHILE THE PATIENT WAS IN FULL CARDIAC ARREST. THE DEVICE WAS TESTED BY THE HOSPITAL BIOMEDICAL ENGINEER AND FOUND NO DEVICE MALFUNCTION. PHILIPS HAS RECEIVED NO INFORMATION SUGGESTING THAT THERE WAS ANY LACK OF AWARENESS OF THIS PATIENT'S STATUS OR THAT THERE WAS ANY DELAY IN THERAPY GIVEN TO THIS PATIENT. THEREFORE, THERE IS NO INDICATION THAT THE USE OF THIS MONITOR WAS A FACTOR IN THE DEATH OF THIS PATIENT. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE AND CHECKED THE DEVICE AND FOUND NO PROBLEMS. IF LEADS ARE NOT ON A PATIENT, THE INTENDED AND EXPECTED FUNCTION OF THIS MONITOR IS TO GIVE A TECHNICAL INOP/ "LEADS OFF" AND TO NOT ALARM FOR ANY PATIENT ARRHYTHMIA. 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 AN MP5 MONITOR WAS GIVING A LEADS OFF MESSAGE, LEADS WHILE THE PATIENT WAS IN FULL CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MP5 MHX PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death