InjuryFMZ
BABYLEO TN500
Received Jun 29, 2026 · Event occurred Jun 23, 2026
Report 9611500-2026-00327 · MDR key 25650430
Device
Product problems
- Insufficient Heating
Patient
NA · Unknown
- Arrhythmia
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE DISPLAYED THE ALARM MESSAGES ¿DEVICE FAILURE, HEATING OFF¿, AND ¿TEMP. OF HUMIDIFIER HEATER HIGH¿. THE HEATING TURNED OFF. THE DEVICE WAS REPLACED. THE PATIENT, AN INFANT WEIGHING 300 G, DEVELOPED AN ARRHYTHMIA.