InjuryFMZ
BABYLEO TN500
Received Jun 1, 2026 · Event occurred Apr 22, 2026
Report 9611500-2026-002560 · MDR key 25347770
Device
Generic name
Neonatology Instruments / Infant Incubator
Manufacturer
Drägerwerk Ag & Co. KgaaModel number
2M61100Product problems
- Temperature Problem
Patient
Not reported
- Burn(s)
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 PATIENT SUFFERED BURNS OVER A LARGE AREA OF THEIR BACK.