MalfunctionFMZ
BABYLEO TN500
Received Dec 30, 2025 · Event occurred Nov 5, 2025
Report 23921128 · MDR key 23921128
Device
Generic name
Incubator, Neonatal
Manufacturer
Draegerwerk Ag & Co. KgaaProduct problems
- Display or Visual Feedback Problem
- Failure to Shut Off
- Therapeutic or Diagnostic Output Failure
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
AN EMPTY DRAGER BABY LEO ISOLETTE WAS ALARMING. UPON INSPECTION IT WAS NOTICED THAT THE SCREEN WAS INDICATING "DEVICE FAILURE, HEATING OFF, CHECK SETTINGS." WHEN STAFF ATTEMPTED TO SILENCE ALARM AND TROUBLESHOOT, THE TOUCH SCREEN WAS NOT WORKING. STAFF WAS NOT ABLE TO SHUT OFF THE ISOLETTE THE TYPICAL WAY. CLINICAL ENGINEERING TEAM WAS CONTACTED AND THE ISOLETTE WAS REMOVED FROM THE NICU FLOOR. THIS DEVICE HAS HAD 11 SERVICE REQUESTS SINCE [REDACTED]-OVER THE LAST 12 MONTHS.