BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR

    MDR report key: 6912808 · Received October 3, 2017

    Report

    Report Number
    2936999-2017-05529
    Event Type
    Death
    Date Received
    October 3, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 4, 2017
    Manufacturer
    MEDIANA CO. LTD.
    Product Code
    DQA
    PMA / PMN Number
    K142865
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THE UNIT DID NOT GENERATE AN ALARM DURING PATIENT USE. IT WAS REPORTED THAT LATER AT AN UNSPECIFIED DATE AND TIME THE PATIENT DIED, MEDTRONIC IS REQUESTING ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691251 NELLCOR OXIMETER DQA MEDIANA CO. LTD. 10005941JP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death