MalfunctionFMZ
Isolette 8000
Received Jul 29, 2026 · Event occurred Jul 16, 2026
Report 2510954-2026-00003 · MDR key 50073402
Device
Product problems
- Unexpected Shutdown
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
An Isolette 8000 Plus incubator was in use with a patient when a hissing sound was heard emanating from the device. Shortly thereafter, the incubator shut down unexpectedly. The humidification function was active at the time of the event. Following the shutdown, attempts to restart the device were unsuccessful, and the incubator remained non-functional. The patient was managed by using alternative means. No adverse patient impact or injury was reported.
Additional Manufacturer Narrative
Draeger has started an investigation, a follow up report will be submitted upon completion.