Expression MR400 MRI Patient Monitoring System (Model MR400)

Description of Event or Problem

It was reported that the CO2 is reading incorrectly. The device was in clinical use. There was no report of patient or user harm.

Additional Manufacturer Narrative

Analysis was performed by remote service personnel and included review of the reported gas measurement failure, evaluation of error messages, review of status logs, and efforts to reproduce the issue. The issue was successfully replicated. The device was unable to measure gases, and the status log showed multiple CO2 hardware failure events over the previous month. It was also confirmed that the O2 cell had been recently replaced by Biomed, indicating that the issue was not related to the O2 cell. Based on the diagnostic findings, the Agent Assembly was identified as the most likely source of the problem. Based on the results of the analysis, it was determined that the product had malfunctioned and the most likely cause of the reported problem was a failure within the Agent Assembly, resulting in repeated CO2 hardware failures and loss of gas measurement functionality. The customer¿s Biomed department was instructed to replace the Agent Assembly. The Biomed team is familiar with this corrective action, having completed the same repair on other MR400 devices. A review of the Service History for this device shows the problem has not been reported again for this device.