BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 1905855 · Received November 18, 2010

    Report

    Report Number
    9610816-2010-00753
    Event Type
    Death
    Date Received
    November 18, 2010
    Report Date
    October 25, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT ALTHOUGH A DEATH OCCURRED AND IT IS NO WAY RELATED TO PHILIPS EQUIPMENT, THE CUSTOMER WANTED TO RETRIEVE PT DATA. THIS IS BEING REPORTED IN ABUNDANT CAUTION DUE TO THE FACT THAT A DEATH OCCURRED. THE CUSTOMER CLEARLY STATED THAT HE IS LOOKING FOR ASSISTANCE ON HOW TO GET A PT'S INFO. THE CUSTOMER STATED THAT PHILIPS EQUIPMENT DID NOT HAVE ANY IMPACT OR RELATIONSHIP TO THE DEATH. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L 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 ALTHOUGH A DEATH OCCURRED AND IT IS NO WAY RELATED TO PHILIPS EQUIPMENT, THE CUSTOMER WANTED TO RETRIEVE PT DATA.

    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