BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR

    MDR report key: 22804809 · Received August 14, 2025

    Report

    Report Number
    2936999-2025-00422
    Event Type
    Death
    Date Received
    August 14, 2025
    Date of Event
    December 1, 2024
    Report Date
    October 15, 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
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: D9, G3, H3, H6 CORRECTION: B5 (EVENT DESCRIPTION), D4 (SERIAL#) H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE ELECTRONIC DEVICE-USE LOGS WERE ALSO PROVIDED. VISUAL INSPECTION NOTED THAT THE EXTERIOR HAD MULTIPLE SMALL AND DEEP SCRATCHES AT THE LOWER FRONT-RIGHT CORNER OF ITS CASING, NEAR ITS CARRYING HANDLE. THE MONITOR WAS RECEIVED WITH AN AC POWER CABLE AND CABLE. FUNCTIONALLY, THE AC POWER CABLE WAS TESTED DURING ANALYSIS FOR PROPER ACTIVATION OF THE MONITOR. AFTER CONNECTING TO AC POWER WITH THE PROVIDED CABLE, THE MONITOR WAS ACTIVATED, WHERE IT PROPERLY PASSED POST AND DEMONSTRATED NO ERRORS. EVALUATION OF THE MONITOR'S SETTINGS FOUND THEM TO BE MISMATCHED WITH THE INFORMATION PROVIDED, WITH THE ALARM LIMITS FOR SATURATION SET AS 90-100 INSTEAD OF 92-100 AND THE ALARM LIMITS FOR PULSE RATE SET AS 60-160 INSTEAD OF 80-200. THE PATIENT MODE SETTING AS PEDIATRIC MATCHED. THE SOFTWARE VERSION WAS 3.70.10, THE SP02 VERSION WAS 1.1.1.0, AND THE VOLUME SETTINGS WERE AT THE MAXIMUM LEVEL OF 8; THESE WERE FOUND TO HAVE THE ALARM SET AT MAXIMUM, THE KEY BEEP SET AT 5, AND THE PULSE TONE SET AT 0. A REVIEW OF THE SYSTEM LOGS SHOWED THE MONITOR'S TREND DATA WAS EVALUATED USING THE NELLCOR ANALYTICS TOOL, WHICH FOUND MULTIPLE LINES OF OVERLAPPING DATA WITH A START DATE OF SEPTEMBER 8TH, 2020. REBOOT OF THE MONITOR FOUND THAT THE TIME AND DATE WOULD RESET TO 11:43:07, SEPTEMBER 8TH, 2020, WHICH ALSO WAS ABNORMAL. THE TIME AND DATE SHOULD HAVE BEEN THROUGH THE MONITOR'S INTERNAL CLOCK ON THE MAIN BOARD, AND THERE SHOULD BE A CONTINUOUS STREAM OF DATA WITH NO OVERLAP. EVALUATION OF THE TABULAR TREND DATA VIA THE MONITOR VERIFIED THE FA ILURE, WITH SEQUENTIAL STREAMS OF DATA WHOSE STARTS WERE EACH AT THE PREVIOUSLY MENTIONED TIME. IT WAS REPORTED THAT A DELAYED ALARM NOTIFICATION AND DEVICE ALARM SYSTEM ISSUE OCCURRED WHILE MONITORING THE PATIENT WHO WAS RECEIVING A FULL-TIME CARE AT HOME. THE DEVICE WAS CONFIGURED TO ALERT FOR OXYGEN DESATURATION AND BRADYCARDIA. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE EVALUATION DETECTED UNREPORTED CONDITIONS: MONITOR EXPERIENCED ONE OR MULTIPLE IMPACTS AT THE LOWER FRONT-RIGHT CORNER OF ITS CASING, WHICH RESULTED IN THE BACK-LEFT THREADED INSERT ON THE TOP CASE TO HAVE BROKEN OFF, ALONG WITH PARTIAL DISLODGING OF THE COIN CELL BATTERY AND RESET OF THE MONITOR'S INTERNAL CLOCK. THE MONITOR WAS OPENED AND INSPECTED, WHERE THE COIN CELL BATTERY ON THE MAIN BOARD WAS FOUND TO BE PARTIALLY DISLODGED FROM ITS FIXTURE AT ABOUT A 45-DEGREE ANGLE, VERIFYING THE INTERNAL CLOCK FAILURE. THE BACK-LEFT THREADED INSERT ON THE TOP CASE WAS ALSO FOUND TO HAVE BROKEN OFF IN ONE PIECE. THESE ISSUES WERE RESOLVED BY RESEATING THE COIN CELL BATTERY BEFORE REBOOTING AND FOUND THAT THE MONITOR PROPERLY RETAINED THE TIME AND DATE WHILE INACTIVE, AND THE MONITOR CASING WAS REPLACED. THE MOST LIKELY CAUSE FOR THESE ADDITIONAL CONDITIONS IS TRACED TO A COMPONENT FAILURE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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 OF THE MONITOR, A DELAYED ALARM NOTIFICATION AND DEVICE ALARM SYSTEM ISSUE OCCURRED WHILE MONITORING THE PATIENT WHO WAS RECEIVING A FULL-TIME CARE AT HOME. THE DEVICE WAS CONFIGURED TO ALERT FOR OXYGEN DESATURATION AND BRADYCARDIA. ON THE DATE OF THE EVENT, THE PATIENT EXPERIENCED BRADYCARDIA, CARDIAC ARREST, LOW OXYGEN SATURATION, RESPIRATORY ARREST, AND DEATH. IT WAS ALLEGED THAT THE DELAYED ALARM NOTIFICATION MAY HAVE AFFECTED THE ABILITY TO RESPOND QUICKLY DURING A CRITICAL DESATURATION EVENT, POTENTIALLY IMPACTING THE OPPORTUNITY TO STIMULATE AND RESUSCITATE THE PATIENT BEFORE REACHING AN UNRECOVERABLE STATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE MONITOR, A DELAYED ALARM NOTIFICATION AND DEVICE ALARM SYSTEM ISSUE OCCURRED WHILE MONITORING THE PATIENT WHO WAS RECEIVING A FULL-TIME CARE AT HOME. THE DEVICE WAS CONFIGURED TO ALERT FOR OXYGEN DESATURATION AND BRADYCARDIA. ON THE DATE OF THE EVENT, THE PATIENT EXPERIENCED BRADYCARDIA, CARDIAC ARREST, LOW OXYGEN SATURATION, RESPIRATORY ARREST, WHICH RESULTED IN DEATH. IT WAS ALLEGED THAT THE DELAYED ALARM NOTIFICATION MAY HAVE AFFECTED THE ABILITY TO RESPOND QUICKLY DURING A CRITICAL DESATURATION EVENT, POTENTIALLY IMPACTING THE OPPORTUNITY TO STIMULATE AND RESUSCITATE THE PATIENT BEFORE REACHING AN UNRECOVERABLE STATE. THE SENSOR WAS PLACED ON THE FOOT. THE PATIENT APPEARED WARM WITH NO APPARENT SKIN TEMPERATURE ABNORMALITIES, HAD NORMAL SKIN TONE, AND NO COSMETIC PRODUCTS, LOTIONS, OR INTRAVASCULAR DYES WERE PRESENT AT THE SENSOR SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924974 NELLCOR OXIMETER DQA COVIDIEN LLC PM100N 10884521196728

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Female Congenital Anomaly| D| L