MalfunctionFMZ
ISOLETTE 8000 PLUS
Received Jun 11, 2026 · Event occurred Mar 30, 2026
Report 2510954-2026-00002 · MDR key 25470861
Device
Product problems
- Unexpected Shutdown
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A PATIENT WAS BEING CARED FOR IN AN INCUBATOR (ISOLETTE) OPERATING AT APPROXIMATELY 80% HUMIDITY. DURING USE, THE CLINICIAN OBSERVED THAT THE INCUBATOR SUDDENLY POWERED OFF, AND NO ELECTRICAL POWER WAS AVAILABLE TO THE DEVICE. THE DEVICE DID NOT ALARM TO ALERT THE USER. THE DEVICE WAS REMOVED FROM USE FOLLOWING THE EVENT. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME HAS BEEN REPORTED.
Additional Manufacturer Narrative
DRAEGER HAS STARTED AN INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.