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	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the expression patient monitor (mr400) indicating that the invasive blood pressure(ibp) is inaccurate.The device was not use on a patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer and replicated the reported issue during the p1 accuracy test.The p1 port failed accuracy testing by reporting 221 when the expected value was 250, while the p2 port passed using the same setup.No error codes were present, and inspection of the pins inside the p1 port found no apparent damage or bending.The possible cause was a defective ibp connector, ibp-2g connector adapter, or ibp board assembly; the exact cause was not confirmed.Philips recommended part numbers to resolve the issue.The system does not meet specifications for the performed service, and the device was not returned to use.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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 ; +1(407)275-3220
• MDR Report Key: 50899390
• Report Number: 1051786-2026-100068
• Device Sequence Number: 14910174
• 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): 09/25/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• 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