EDI CATHETER ENFIT 6FR/49 CM, 5PCS
Received Jun 1, 2026 · Event occurred Mar 2, 2026
Report 8010042-2026-0000705 · MDR key 25346012
Device
Generic name
Gastrointestinal Tubes With Enteral Specific Connectors
Manufacturer
Maquet Critical Care AbModel number
6883898Lot number
UNKNOWN
Product problems
- Material Frayed
- Failure to Analyze Signal
Patient
Not reported
- Pain
- Discomfort
Narrative
Additional Manufacturer Narrative
THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE LOT NUMBER HAS NOT BEEN PROVIDED.
Description of Event or Problem
IT WAS REPORTED THAT DURING VENTILATION TREATMENT IN NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT. THE EDI SIGNAL MEASURED BY THE EDI CATHETER WAS IRREGULAR. THE EDI CATHETER WAS REMOVED AND TREATMENT CONTINUED WITH ANOTHER VENTILATION MODE. THE PATIENT CALMED DOWN. AFTER REMOVAL OF THE EDI CATHETER, IT WAS NOTED THAT THE ELECTRODE ARRAYS ON THE CATHETER TIP WERE DAMAGED AND WERE PROTRUDING FROM THE CATHETER TUBE. FINAL OUTCOME WAS NO HARM TO THE PATIENT. MANUFACTURER¿S REF #: (B)(4).