BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2091087 · Received May 4, 2011

    Report

    Report Number
    9610816-2011-00205
    Event Type
    Death
    Date Received
    May 4, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 9, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT ALTHOUGH A PATIENT ALARM OCCURRED, THE USER FELT THAT THE TIME LIMIT FOR THE ALARM WAS SHORTENED. THE PATIENT TOOK THEMSELVES OFF OF THE MONITOR AND THE PATIENT 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 ALTHOUGH A PATIENT ALARM OCCURRED, THE USER FELT THAT THE TIME LIMIT FOR THE ALARM WAS SHORTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP70 INTELLIVUE PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death