MalfunctionBSK
INTELLICUFF
Received Jun 26, 2026 · Event occurred May 13, 2026
Report 3001421318-2026-00391 · MDR key 25632712
Device
Product problems
- Unexpected Shutdown
Patient
NA · Unknown
- Low Oxygen Saturation
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
HAMILTON MEDICAL AGS REFERENCE: (B)(4); INVESTIGATION IS ONGOING.
Description of Event or Problem
HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION): "HAMILTON MEDICAL CONTINUOUS CUFF MONITOR STARTED FLASHING SUDDENLY WHICH DEFLATED THE ET CUFF, CAUSING THE PATIENTS SATS TO DROP TO 84%. DEVICE WAS CHECKED ON NURSING SAFETY CHECKS POST HANDOVER AND WAS WORKING WELL - WITHIN 20 MINUTES OF CHECKING THE INCIDENT OCCURRED." THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.