MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION MR400 MRI PATIENT MONITORING SYSTEM (MODEL MR400)

Model Number	EXPRESSION MR400 MRI PATIENT MONITOR SYS
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following functional tests were performed: the philips remote support engineer (rse) talked to the customer who confirmed the co2 sensor was already replaced on october 10th and also calibrated at that time.As well the sample line and the water trap were replaced but the issue remained.The customer was advised by the rse to perform the agent verification test according to the service guide.The rse advised to change the co2 sensor and follow up if the issue still exists.The rse made several attempts to follow up with the customer, but the customer was not available for follow up, no response from customer.The case was closed with insufficient information, based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.We are unable to confirm the final disposition of the device, because the customer did not respond to requests for additional information.The investigation concludes that no further action is required at this time.
Event or Problem Description
It was reported the co2 numbers are drifting low outside of service manual specs.Over minus 4 from 38.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: EXPRESSION MR400 MRI PATIENT MONITORING SYSTEM (MODEL MR400)
• Common Device Name: EXPRESSION MR400 MRI PATIENT MONITORING SYSTEM (MODEL MR400)
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer (Section G): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer Contact: deborah currlin ; 12151 research parkway; orlando, FL 32826 ; 4072753220
• MDR Report Key: 23593811
• Report Number: 1051786-2025-000015
• Device Sequence Number: 21362413
• Product Code: MWI
• UDI-Device Identifier: 00884838039131
• UDI-Public: (01)00884838039131
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K152330
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EXPRESSION MR400 MRI PATIENT MONITOR SYS
• Device Catalogue Number: 866185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown