BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR N200 PULSE OXIMETER

    MDR report key: 203000 · Received December 16, 1998

    Report

    Report Number
    2025525-1998-00040
    Event Type
    Death
    Date Received
    December 16, 1998
    Report Date
    December 16, 1998
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON NOVEMBER 20, 1998 NELLCOR PURITAN BENNETT REC'D INFO ALLEGING AN INCIDENT HAD OCCURRED WHERE A PT HAD DIED WHILE BEING CONNECTED TO AN N-200 PULSE OXIMETER. REPORTEDLY, THE N200 WAS PROVIDING A READING OF 96 SAT AND 110 RATE WHEN THE PT WAS FOUND DEAD BY A PHYSICIAN WHILE MAKING HIS ROUNDS. ACCORDING TO THE REPORTER, THE N200 HAS BEEN RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR N200 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death AVEOLAR HAMILTON VENTILATOR.