BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR N-3000

    MDR report key: 398861 · Received June 12, 2002

    Report

    Report Number
    2025525-2002-00009
    Event Type
    Death
    Date Received
    June 12, 2002
    Date of Event
    May 13, 2002
    Report Date
    May 13, 2002
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT REC'D INFO THAT ALLEGED A PT HAD EXPIRED WHILE BEING MONITORED BY AN N-3000 PULSE OXIMETER. ACCORDING TO THE FAMILY, "UNIT DID NOT ALARM, UNTIL THE SENSOR WAS REMOVED FROM THE PT". NO FURTHER INFO HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR N-3000 PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death