BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR

    MDR report key: 22493536 · Received July 14, 2025

    Report

    Report Number
    2936999-2025-00374
    Event Type
    Death
    Date Received
    July 14, 2025
    Date of Event
    July 1, 2022
    Report Date
    July 14, 2025
    Manufacturer
    COVIDIEN LLC
    Product Code
    DQA
    UDI-DI
    10884521196728
    PMA / PMN Number
    K142865
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE MONITOR FAILED TO ALARM, RESULTING IN THE PATIENT'S CARDIAC ARREST AND SUBSEQUENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317262 NELLCOR OXIMETER DQA COVIDIEN LLC PM100N 10884521196728

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Unknown Death