MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB EDI CATHETER ENFIT 6FR/49 CM, 5PCS; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	6883898
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during ventilator treatment in nava (neurally adjusted ventilatory assist) mode, an alarm for edi catheter failure was generated.The patient desaturated to 50% and became bradycardic.The edi catheter was replaced, and the patient stabilized.Final patient outcome was no harm.Manufacturer¿s ref #: (b)(4).
Additional Manufacturer Narrative
It was claimed that during ventilator treatment in nava (neurally adjusted ventilatory assist) mode, an alarm for edi catheter error was generated.The patient desaturated to 50% and became bradycardic.The edi catheter was replaced, and the patient stabilized.The edi catheter was in place for less than one hour.After replacement, ventilation in nava mode continued.Neither the edi catheter nor the logs from the connected ventilator have been available for further evaluation.A review of manufacturing records for the stated batch number confirmed that all manufacturing parameters were within specified limits.According to the user¿s manual, the recommended action for the generated alarm for edi catheter error is to replace the edi catheter.Due to the lack of the replaced edi catheter and ventilator logs, the root cause of the generated alarm for edi catheter error has not been conclusively established.
Event or Problem Description
Manufacturer's ref #: (b)(4).

• Brand Name: EDI CATHETER ENFIT 6FR/49 CM, 5PCS
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 24243471
• Report Number: 8010042-2026-0000137
• Device Sequence Number: 9618265
• Product Code: PIF
• UDI-Device Identifier: 17325710004606
• UDI-Public: (01)17325710004606(11)250718(17)270718(10)3000493558(30)5
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2026
• Device Model Number: 6883898
• Device Lot Number: 3000493558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown