MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION MR400 MRI PATIENT MONITORING SYSTEM (MODEL MR400); MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	EXPRESSION MR400 MRI PATIENT MONITOR SYS
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips field service engineer (fse) reviewed the device log and confirmed that an unintentional shutdown had occurred.The fse was unable to reproduce the phenomenon but determined that the main control board of the device is defective and would need to be replaced.The main board was replaced.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).
Event or Problem Description
It was reported that the device froze and suddenly shut down.The device was in use on a patient at the time of the event.There was no adverse event reported.

• Brand Name: EXPRESSION MR400 MRI PATIENT MONITORING SYSTEM (MODEL MR400)
• Common Device Name: MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• 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: 23465125
• Report Number: 1051786-2025-000014
• Device Sequence Number: 15682472
• Product Code: MWI
• UDI-Device Identifier: 00884838039131
• UDI-Public: (01)00884838039131
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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