BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYLEO TN500

    MDR report key: 24035526 · Received January 12, 2026

    Report

    Report Number
    9611500-2026-00005
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    January 2, 2026
    Report Date
    March 9, 2026
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    FMZ
    UDI-DI
    04048675436607
    PMA / PMN Number
    K162821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE TEMPERATURE PROBES SHOWED A DISCREPANCY IN THE SKIN TEMPERATURE RESULTING IN THE DEVICE OVERHEATING THE PATIENT. THE INVESTIGATION WAS BASED ON THE LOG FILE OF THE AFFECTED DEVICE AND THE RETURNED TEMPERATURE PROBES. BASED ON THE ANALYSIS OF THE LOG FILE THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE WAS NOT OPERATED IN SKINMODE AS REPORTED, BUT INSTEAD IN MANUALMODE. IN THAT MODE, THE TEMPERATURE IS NOT REGULATED BASED ON THE MEASURED SKIN TEMPERATURE. THE LOG FILE ANALYSIS SHOWED THAT THE SKIN TEMPERATURE PROBES WERE NOT SECURED PROPERLY TO THE PATIENT, AS THE MEASURED SKIN TEMPERATURE WAS SLOWLY DECLINING TOWARDS AIR TEMPERATURE. AT 02:20 PM, THE SKIN TEMPERATURE PROBES WERE RECONNECTED TO THE PATIENT AND THE DEVICE MEASURE A SKIN TEMPERATURE OF 35.22°C. THE REPORTED TEMPERATURE OF 38.1°C WAS NOT REACHED ACCORDING TO THE LOG FILE. ADDITIONALLY, THE DEVICE WAS OPERATED IN OPEN CARE. AS A RESULT, THE CONVECTIVE HEATER WAS TURNED OFF DURING THE REPORTED EVENT. ALSO, THE RADIANT WARMER WAS POWERED OFF SINCE THE DEVICE HAD BEEN TURNED ON AT 11:50 AM. THEREFORE, IT COULD NOT BE CONFIRMED THAT THE ADDITIONAL HEAT WAS COMING FROM THE DEVICE. TESTING OF THE PROVIDED TEMPERATURES PROBES SHOWED THAT ALL TEMPERATURE PROBES ARE WITHIN THE MANUFACTURER´S SPECIFICATION AND MEASURE THE CORRECT RESISTANCE/TEMPERATURE IN RELATION TO THE CALIBRATED TEMPERATURE PROBE. SKIN CONTROL TESTS WERE PERFORMED BY THE DRÄGER SERVICE ON THE DEVICE AND FOUND TO BE SUCCESSFUL. NO DEVIATION IN THE DEVICE OR SKIN TEMPERATURE PROBES COULD BE IDENTIFIED. FURTHER INFORMATION ABOUT THE TEST METHOD WITH THE FLUKE INCU II WAS REQUESTED BUT NOT PROVIDED. THE VALUES OF THE SKIN TEMPERATURE ARE MEASURED BY THE BABYLEO WITH A TEMPERATURE PROBE AND COMPARED TO THE SET VALUES. IF OPERATED IN SKIN MODE A DEVIATION EXCEEDING THE ALARM LIMITS WILL RESULT IN A VISUAL AND AUDIBLE ALARM. THE PATIENT TEMPERATURE IS THUS REGULATED AND MONITORED. IN ADDITION, THE INSTRUCTION FOR USE REQUESTS TO CHECK THE PATIENT TEMPERATURE REGULARLY WITH AN INDEPENDENT THERMOMETER TO REMEDY FALSE SET VALUES, CHANGES IN PATIENT HEALTH OR POSSIBLE DEVICE OR PROBE FAILURES. THE RESULTS OF THE INVESTIGATION DID NOT REVEAL ANY NEW RISKS WHICH ARE NOT COVERED BY THE PRODUCT RISK MANAGEMENT FILE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INCONSISTENT TEMPERATURES WERE DISPLAYED ON THE DEVICE. UNIT PULLED FROM SERVICE. BCHS0005001 SN: (B)(6). BABYLEO TESTED WITH 2 NEW DISPOSABLE PROBES. PN:MX11000 LOT#241220 EXP.DATE:2027-11-19 STATIC TEMPERATURE TEST READ AT 36 DEGREES WITH A SET TEMPERATURE OF 36 DEGREES FOR BOTH CENTRAL AND PERIPHERAL USING TEST KIT 7911314 (DRAEGER) THIS SHOWS THE TN500 ITSELF WAS READING RESPECTIVE RESISTANCES PROPERLY. TESTING WITH THE 2 DISPOSABLE TEMPERATURE PROBES (USING THE FLUKE INCU II SKIN TEMPERATURE TEST KIT) (PROBE 1 SET TO 36.04 AND WAS READ AT 35.2 DEGREES. SHOWING A FAIL WITH PROBE 1) - SHOWING A CONSISTENCY WITH THE REPORTED FAILURE. (PROBE 2 SET TO 36.00 AND WAS READ AT 35.2 DEGREES. SHOWING A FAIL WITH PROBE 2) - SHOWING A CONSISTENCY WITH THE REPORTED FAILURE. BOTH PROBES HAD A RESISTANCE OF 1458 OHMS WHEN INCU II WAS SET TO 36.0 DEGREES. THE UNIT IS PROGRAMMED FOR 1412 OHMS AT 36 DEGREES AS PER SERVICE MANUAL. MAIN ISSUE : ¿BABYLEO IN NICU OVERHEATED BABY GIVING THEM A FEVER, THIS DELAYED DISCHARGE BABY'S ADMISSION TEMP 38.1C AND WAS PLACED UNDER NICU 9A BABYLEO WITH SKIN TEMP PROBE PLACED AND WARMER SET TO "SKIN MODE" AT 1320. BABY'S TEMPERATURE TRENDING DOWN, TEMP AT 1400 WAS 37.5C. MD AT BEDSIDE AT 1500, 1 HOUR LATER AND WAS PLANNING TO DISCHARGE BABY TO POST PARTUM. MD ASKED WRITER IF BABY'S TEMPERATURE HAD BEEN OK, WRITER STATED TO MD THAT TEMP WAS TRENDING DOWN AND THEN CHECKED TEMP AT BEDSIDE WITH MD. AT 1500 BABY'S TEMPERATURE WAS BACK TO 38.1C, RADIANT HEAT NOTED TO BE COMING FROM WARMER WHILE WARMER REGISTERING BABY'S CORE TEMP AS 36.8C. WARMER WAS SHUT OFF AT THIS TIME AND BABY WAS TAKEN OUT OF LEO BED TO FEED. TEMPERATURE HAD GONE DOWN TO 37.2C AFTER 20MIN OF BEING REMOVED FROM THE LEO.¿ ACCORDING TO THE INITIAL LOG ANALYSIS, THE DEVICE WAS NOT IN SKIN MODE AND NOT WARMING AT THE REPORTED TIME. IT CAN BE EXPECTED THAT THE PAT. CONDITION OR USE ERROR LED TO THE EVENT OR THE MEASURING SENSORS OF THE MEASURING KIT HAD A DEVIATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INCONSISTENT TEMPERATURES WERE DISPLAYED ON THE DEVICE. UNIT PULLED FROM SERVICE. BCHS0005001 SN: (B)(6) BABYLEO TESTED WITH 2 NEW DISPOSABLE PROBES. PN:MX11000 LOT#241220 EXP.DATE:2027-11-19 STATIC TEMPERATURE TEST READ AT 36 DEGREES WITH A SET TEMPERATURE OF 36 DEGREES FOR BOTH CENTRAL AND PERIPHERAL USING TEST KIT 7911314 (DRAEGER) THIS SHOWS THE TN500 ITSELF WAS READING RESPECTIVE RESISTANCES PROPERLY. TESTING WITH THE 2 DISPOSABLE TEMPERATURE PROBES (USING THE FLUKE INCU II SKIN TEMPERATURE TEST KIT) (PROBE 1 SET TO 36.04 AND WAS READ AT 35.2 DEGREES. SHOWING A FAIL WITH PROBE 1) - SHOWING A CONSISTENCY WITH THE REPORTED FAILURE. (PROBE 2 SET TO 36.00 AND WAS READ AT 35.2 DEGREES. SHOWING A FAIL WITH PROBE 2) - SHOWING A CONSISTENCY WITH THE REPORTED FAILURE. BOTH PROBES HAD A RESISTANCE OF 1458 OHMS WHEN INCU II WAS SET TO 36.0 DEGREES. THE UNIT IS PROGRAMMED FOR 1412 OHMS AT 36 DEGREES AS PER SERVICE MANUAL. MAIN ISSUE : ¿BABYLEO IN NICU OVERHEATED BABY GIVING THEM A FEVER, THIS DELAYED DISCHARGE BABY'S ADMISSION TEMP 38.1C AND WAS PLACED UNDER NICU 9A BABYLEO WITH SKIN TEMP PROBE PLACED AND WARMER SET TO "SKIN MODE" AT 1320. BABY'S TEMPERATURE TRENDING DOWN, TEMP AT 1400 WAS 37.5C. MD AT BEDSIDE AT 1500, 1 HOUR LATER AND WAS PLANNING TO DISCHARGE BABY TO POST PARTUM. MD ASKED WRITER IF BABY'S TEMPERATURE HAD BEEN OK, WRITER STATED TO MD THAT TEMP WAS TRENDING DOWN AND THEN CHECKED TEMP AT BEDSIDE WITH MD. AT 1500 BABY'S TEMPERATURE WAS BACK TO 38.1C, RADIANT HEAT NOTED TO BE COMING FROM WARMER WHILE WARMER REGISTERING BABY'S CORE TEMP AS 36.8C. WARMER WAS SHUT OFF AT THIS TIME AND BABY WAS TAKEN OUT OF LEO BED TO FEED. TEMPERATURE HAD GONE DOWN TO 37.2C AFTER 20MIN OF BEING REMOVED FROM THE LEO.¿ ACCORDING TO THE INITIAL LOG ANALYSIS, THE DEVICE WAS NOT IN SKIN MODE AND NOT WARMING AT THE REPORTED TIME. IT CAN BE EXPECTED THAT THE PAT. CONDITION OR USE ERROR LED TO THE EVENT OR THE MEASURING SENSORS OF THE MEASURING KIT HAD A DEVIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387661 BABYLEO TN500 NEONATOLOGY INSTRUMENTS / INFANT INCUBATOR FMZ DRÄGERWERK AG & CO. KGAA 2M60000 04048675436607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NA.| NA.