MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB EDI CATHETER ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number ENFIT 6FR EDI CATHETER

Device Problem Failure to Analyze Signal (1539)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/14/2019

Event Type  Injury  

Event Description

It was reported that there was self-triggering of the ventilator while it was connected to a patient.At the time, the edi catheter was inserted in the patient.It was further stated that the situation was realized when the patient¿s situation got worse with saturation going down.According to the hospital the self-triggering could only be stopped by simv mode of ventilation or pushing the edi catheter further down into the patient.The edi catheter was removed from the patient.The drop of the saturation level is unknown.The final patient outcome was no injury.The edi catheter is a single use feeding tube with measuring electrodes for picking up edi signals during nava (neurally adjusted ventilatory assist) ventilation that are used to control the ventilator and assist the patient's breathing in proportional to and in synchrony with the patient¿s own efforts.(b)(4).

Manufacturer Narrative

It was reported that there was self-triggering of the ventilator while it was connected to a patient.At the time, the edi catheter was inserted in the patient.It was further stated that the situation was realized when the patient¿s situation got worse with saturation going down.According to the hospital the self-triggering could only be stopped by simv mode of ventilation or pushing the edi catheter further down into the patient.The edi catheter was removed from the patient and returned for investigation.There were two edi catheters received for investigation, without any sign or indication which one was involved in the event.The two edi catheters were investigated.Visual analysis found no anomalies and electrical measurements were as expected.No deviations were found on any of the two returned edi catheters ventilator log files have not been received.Provided screen shots have confirmed the event.The root cause of the reported self-triggering of the ventilator has not been determined.

Event Description

Manufacturer's ref #: (b)(4).

• Brand Name: EDI CATHETER ENFIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9289718
• MDR Text Key: 165395563
• Report Number: 8010042-2019-00815
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• PMA/PMN Number: K153688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENFIT 6FR EDI CATHETER
• Device Catalogue Number: 6883898
• Device Lot Number: 92272052
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening