BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR

    MDR report key: 22705536 · Received August 4, 2025

    Report

    Report Number
    2936999-2025-00407
    Event Type
    Death
    Date Received
    August 4, 2025
    Date of Event
    February 19, 2024
    Report Date
    December 29, 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 Location
    MD, US
    Reporter Occupation
    003

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5,H1,H2. 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 THE PATIENT HAD BEEN USING THE MONITOR, WHICH WAS CONNECTED TO THE DEVICE AND APPEARED TO BE FUNCTIONING AS EXPECTED WHEN THE VIDEO MONITOR WAS CHECKED AT 3:00 AM. HOWEVER, BY 7:00 AM, THE OXYGEN SATURATION LEVEL HAD DROPPED TO 50, AND THE MONITOR WAS FLASHING BUT NOT ALARMING. THE PATIENT HAD TURNED BLUE, PROMPTING CPR TO BE INITIATED AND 911 TO BE CALLED. THE PATIENT WAS RESUSCITATED AND TRANSPORTED TO THE HOSPITAL, WHERE HE WAS DIAGNOSED WITH HYPOXIC-ISCHEMIC ENCEPHALOPATHY (HIE), A BRAIN INJURY CAUSED BY INSUFFICIENT OXYGEN SUPPLY. UNFORTUNATELY, THE PATIENT WAS RENDERED BRAIN-DEAD AS A RESULT OF THE INCIDENT-FROM (B)(6)-IT WAS REPORTED THAT DURING USE, THE UNIT FLASHED BUT WITH NO AUDIBLE SOUND WHEN THE PATIENT¿S SPO2 WENT DOWN TO 50% AND THE PATIENT TURNED BLUE. THE MOTHER STARTED CPR AND 911 WAS CALLED. THE SON WAS RESUSCITATED AND WAS TAKEN TO THE HOSPITAL BUT WAS LATER DIAGNOSED WITH HYPOXIC-ISCHEMIC ENCEPHALOPATHY (HIE) THAT RENDERED THE PATIENT BRAIN DEAD. THE UNIT WAS REPORTED NOT IN SLEEP STUDY MODE AND HAD AUDIBLE ALARM PRIOR TO THE EVENT. DUPLICATE OF (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN USING THE MONITOR, WHICH WAS CONNECTED TO THE DEVICE AND APPEARED TO BE FUNCTIONING AS EXPECTED WHEN THE VIDEO MONITOR WAS CHECKED AT 3:00 AM. THE MONITOR SETTINGS WERE: HR HIGH 160, HR LOW 80, O2 HIGH 100, AND O2 LOW 89. HOWEVER, BY 7:00 AM, THE OXYGEN SATURATION LEVEL HAD DROPPED TO 50, AND THE MONITOR WAS FLASHING BUT NOT ALARMING. THE PATIENT HAD TURNED BLUE, PROMPTING CPR TO BE INITIATED AND 911 TO BE CALLED. THE PATIENT WAS RESUSCITATED AND TRANSPORTED TO THE HOSPITAL, WHERE HE WAS DIAGNOSED WITH HYPOXIC-ISCHEMIC ENCEPHALOPATHY (HIE), A BRAIN INJURY CAUSED BY INSUFFICIENT OXYGEN SUPPLY. UNFORTUNATELY, THE PATIENT WAS RENDERED BRAIN-DEAD AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199535 NELLCOR OXIMETER DQA COVIDIEN LLC PM100N 10884521196728

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Male Hospitalization| S| L