EDI CATHETER ENFIT
Received Mar 16, 2026 · Event occurred Jan 21, 2026
Report 8010042-2026-0000366 · MDR key 24604782
Device
Generic name
Gastrointestinal Tubes With Enteral Specific Connectors
Manufacturer
Maquet Critical Care AbModel number
UNKNOWNLot number
UNKNOWN
Product problems
- Output Problem
Patient
NA · Unknown
- Low Oxygen Saturation
Narrative
Additional Manufacturer Narrative
SINCE MODEL AND LOT # IS UNKNOWN, UDI INFORMATION AND MANUFACTURING DATE IS UNKNOWN.
Description of Event or Problem
IT WAS REPORTED THAT DURING PATIENT TREATMENT IN NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE, THERE WERE ALARMS GENERATED FOR ¿EDI SIGNAL INTERFERENCE FROM ECG¿ AND ¿EDI SIGNAL INVALID¿. HIGH RESPIRATORY RATE WAS DELIVERED AND THE PATIENT DERECRUITED, WITH SATURATIONS DROPPING TO 70% AND LARGE VOLUMES OF AIR WAS ACCUMULATED IN THE STOMACH. MANUAL VENTILATION WAS INITIATED TO STABILIZE THE PATIENT, AND THE EDI CATHETER WAS REPLACED. FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER¿S REF #: (B)(4).