Babyleo TN500 2M60000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048675436607), received between Jul 5, 2019 and Feb 13, 2026 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Insufficient Heating; Use of Device Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT EXTREMELY PREMATURE (26 WEEKS + 4 DAYS), TRANSFERRED TO THE DEPARTMENT IN A HURRY FOR AN EMERGENCY CAESAREAN SECTION. TEMPERATURE OF 34.5°C AT BIRTH, NEWBORN PLACED IN AN INCUBATOR WITH TEMPERATURE INCREASE IN MANUAL MODE AND OBSERVATION THAT THE TEMPERATURE PROBE WAS NO LONGER IN PLACE, EXPLAINING THE LOW TEMPERATURE. THE TEMPERATURE PROBE WAS REPLACED ON THE NEWBORN, AND IN THE RUSH BEFORE EMERGENCY INTUBATION, AN ERROR WAS MADE BY THE PROFESSIONAL WHO DID NOT PROPERLY VALIDATE THE ¿SKIN MODE¿ ON THE INCUBATOR (REQUIRING TWO PRESSES OF THE BUTTON). THE SKIN MODE ALLOWS THE TEMPERATURE TO BE ADJUSTED TO THE NEWBORN'S TEMPERATURE, WHEREAS THE DEFAULT MANUAL MODE INCREASES THE INCUBATOR TEMPERATURE ONLY DURING THE FIRST 15 MINUTES OF USE. DURING INTUBATION, THE INCUBATOR DISPLAYS 34.7 °C (TOO LOW) AND THE HEART RATE IS MEASURED AT BETWEEN 106 AND 118/MINUTE. FOLLOWING INTUBATION, THE NEWBORN'S TEMPERATURE IS MEASURED IN THE ARMPIT AT 33°C: IT IS THEN NOTED THAT THE INCUBATOR - PREVIOUSLY IN MANUAL MODE - IS NO LONGER HEATING (THE 15 MINUTES OF USE HAVE BEEN REACHED). THE PROFESSIONAL CERTAINLY MISTAKENLY THOUGHT THAT THE TEMPERATURE PROBE WAS NO LONGER IN PLACE,

  Patient problems: Bradycardia

  MAUDE report 24331163 ↗
• MalfunctionJan 12, 2026Use of Device Problem; No Apparent Adverse Event

  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

  Patient problems: Fever

  MAUDE report 24035526 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Excessive Heating; Adverse Event Without Identified Device or Use Problem; Excessive Heating

  IT WAS REPORTED, THAT A NEONATE WITH AN APPROXIMATE WEIGHT OF 700 GRAMS GAINED SKIN BURN AT THE BACK DURING USE WITH THE HEATED MATTRESS IN A BABYLEO TN500. BASED ON THE CURRENT INFORMATION A FAILURE AT THE DEVICE / MATTRESS THAT RESULTED IN A SKIN BURN CANNOT BE EXCLUDED.

  Patient problems: Burn(s)

  MAUDE report 16626093 ↗
• InjuryDec 22, 2020Unexpected Therapeutic Results; Decreased Sensitivity; Device Sensing Problem; Unexpected Therapeutic Results; Decreased Sensitivity; Device Sensing Problem

  IT WAS REPORTED BY THE USER: ¿PREMATURE BABY IN THE INCUBATOR, CONSPICUOUS WITH INCREASING LIFE-THREATENING HYPERNATREMIA (MAX. 160 MMOL/L) AND HYPERKALEMIA (MAX 7.5 MMOL/L) DESPITE VERY HIGH FLUID INTAKE UP TO 220ML/(KG*H). NO WEIGHT GAIN, LITTLE URINE EXCRETION AND TEMPERATURE LABILITY DESPITE THE ATYPICALLY HIGH INCUBATOR TEMPERATURE OF 37°C. WHEN VIEWED TOGETHER, THE ONLY POSSIBLE CAUSE IS VERY STRONG TRANSDERMAL FLUID LOSS. INCUBATOR REGULATED UP FROM 80% TO 99% RELATIVE HUMIDITY (STATED MEASURED VALUES OF THE INCUBATOR IN THE EXPECTED RANGE, BUT NO PRECIPITATION ON THE INCUBATOR WALLS). THEREFORE THE INCUBATOR WAS REPLACED, WHICH RESULTED IN THE CHILD GRADUALLY STABILIZING.¿

  Patient problems: Hypernatremia

  MAUDE report 11054309 ↗
• DeathJul 5, 2019Therapeutic or Diagnostic Output Failure

  PLEASE REFER TO THE INITIAL REPORT.

  Patient problems: Death

  MAUDE report 8763674 ↗