MalfunctionBSK
INTELLICUFF
Received Apr 9, 2026 · Event occurred Mar 18, 2026
Report 3001421318-2026-00204 · MDR key 24826716
Device
Product problems
- Gas Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
HAMILTON MEDICAL AGS REFERENCE:(B)(4). HAMILTON MEDICAL AGS CONCLUSION: INVESTIGATION IS ONGOING.
Description of Event or Problem
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: INTELLICUFF IS NOT WORKING, SCREEN BLINKING ISSUE WITH PATIENT INVOLVEMENT. NO HEALTH CONSEQUENCES OR IMPACT AND NO INTERVENTION NECESSARY, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.