BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX800 PATIENT MONITOR

    MDR report key: 2800368 · Received October 11, 2012

    Report

    Report Number
    9610816-2012-00449
    Event Type
    Death
    Date Received
    October 11, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 8, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE MX800 MONITOR DID NOT ALARM AN SPO2 ALARM AND A PT DIED. THIS COMPLAINT WAS DEEMED REPORTABLE DUE TO THE FACT THAT THE CUSTOMER ALLEGES THE MX800 MONITOR WAS A FACTOR IN A PT'S DEATH DUE TO THE FACT THE MONITOR DID NOT ALARM AN SPO2 VITAL ALARM. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT 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 THE MX800 MONITOR DID NOT ALARM AN SPO2 ALARM AND A PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MX800 PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 865240 (MX800) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death