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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.E1: reporting institution phone#: (b)(6).
Event or Problem Description
Philips received a complaint on an expression patient monitor (mr400) indicating that the equipment displays non-compliant oximetry readings.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.Additional information has been requested to clarify how the readings were non-compliant.
Additional Manufacturer Narrative
Multiple attempts were made to obtain the device context of use, evaluation, repair, and operational status with no response from the customer.No further information was provided.A supplemental report will be submitted if new information is obtained.

• 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: 21885424
• Report Number: 1051786-2025-000009
• Device Sequence Number: 11621473
• Product Code: MWI
• UDI-Device Identifier: 00884838039131
• UDI-Public: (01)00884838039131
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2018
• 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