BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS MULTIPARAMETER PATIENT MONITOR

    MDR report key: 1802745 · Received August 11, 2010

    Report

    Report Number
    1218950-2010-01287
    Event Type
    Death
    Date Received
    August 11, 2010
    Report Date
    August 6, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE PT HAD ALREADY EXPIRED PRIOR TO BEING CONNECTED TO THE MONITOR, AND THAT THE MONITOR WAS NOT CONSIDERED TO BE A CONTRIBUTING FACTOR IN THE PT'S DEATH. THIS IS BEING REPORTED ONLY BECAUSE A PHILIPS DEVICE WAS IN USE ON A PT WHO DIED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT HAD EXPIRED BEFORE BEING CONNECTED TO A PHILIPS MONITOR. THE MONITOR STILL GAVE SOME VALUES FOR HR AND NIBP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MULTIPARAMETER PATIENT MONITOR MHX PHILIPS HEALTHCARE 863074

    Patients

    Seq Age Sex Outcome Treatment
    1