BEUDAMED
    FDA Adverse Event Death Summary report: N

    MON-A-THERM

    MDR report key: 23241405 · Received October 7, 2025

    Report

    Report Number
    9681384-2025-01060
    Event Type
    Death
    Date Received
    October 7, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 7, 2025
    Manufacturer
    COVIDIEN AG JUAREZ (MMJ)
    Product Code
    FLL
    PMA / PMN Number
    K874514
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 OF THE PROBE ON A NEWBORN WITH SEVERE NEONATAL ANOXIC-ISCHEMIA AT 7:30AM, INCONSISTENT RECTAL TEMPERATURE READINGS WERE OBSERVED DURING HYPOTHERMIA THERAPY. THE MONITOR INDICATED THE PROBE TEMPERATURE OF 33.5°C, WHILE THE WATER TEMPERATURE WAS 40°C. THE WARMING TABLE WAS ON AND THE MATTRESS WAS AT 30°C. THE CHILD'S TEMPERATURE WAS RECHECKED AXILLARY AND FOUND TO BE 36.6°C. THE SAME INCIDENT OCCURRED AGAIN THE SAME DAY AT 9:00PM. THE RECTAL PROBE WAS SUBSEQUENTLY REPLACED AND RECONNECTED, AND THE WARMING TABLE WAS TURNED OFF. COOLING WAS TEMPORARILY PAUSED WHILE AWAITING THE PHYSICIAN'S DECISION, AFTER WHICH HYPOTHERMIA THERAPY WAS RESUMED WITHIN HOURS. UPON REVIEWING THE MACHINE¿S LOG FILE, A SUDDEN LOSS OF TEMPERATURE MONITORING WAS NOTED, INDICATING A BREAKAGE IN THE CONNECTION CABLE AND DISCONNECTION OF THE PROBE. THE CABLE¿S FUNCTIONALITY WAS VERIFIED; HOWEVER, THE PROBE WAS NOT RETAINED FOR FURTHER EVALUATION. THE DEATH OCCURRED FOLLOWING THE WITHDRAWAL OF ACTIVE THERAPIES BASED ON MEDICAL DECISION DUE TO THE VERY POOR NEUROLOGICAL PROGNOSIS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566380 MON-A-THERM THERMOMETER, ELECTRONIC, CLINICAL FLL COVIDIEN AG JUAREZ (MMJ) 90050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death