InjuryFMZ
BABYLEO TN500
Received Jun 17, 2026 · Event occurred Jun 1, 2026
Report 9611500-2026-00304 · MDR key 25530251
Device
Product problems
- Insufficient Heating
Patient
Unknown
- Alteration in Body Temperature
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HAD SHOWN A SIGNIFICANT DROP IN BODY TEMPERATURE. THE PATIENT HAD TO BE REMOVED FROM THE INCUBATOR AND INTUBATED.
Additional Manufacturer Narrative
THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.