BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3155 RELEASE L.0 UPGRADE

    MDR report key: 2111675 · Received May 27, 2011

    Report

    Report Number
    1218950-2011-01484
    Event Type
    Death
    Date Received
    May 27, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 5, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K062271
    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 A PATIENT DEATH OCCURRED AND THEY BELIEVE THE PATIENT WAS OFF THE MONITOR FOR AN EXTENDED PERIOD OF TIME WHICH CONTRIBUTED TO THIS EVENT. THE CUSTOMER IS UNCERTAIN IF THE DEVICE MALFUNCTIONED. 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 PATIENT DEATH OCCURRED AND THEY BELIEVE THE PATIENT WAS OFF THE MONITOR FOR AN EXTENDED PERIOD OF TIME WHICH CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M3155 RELEASE L.0 UPGRADE MHX PHILIPS HEALTHCARE M3155

    Patients

    Seq Age Sex Outcome Treatment
    1 Death