MAUDE Adverse Event Report: Invivo, a division of Philips Medical Systems MR Patient Care Expression Model MR400 MRI Patient Monitoring System; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Model Number	Expression MR400 MRI Patient Monitor Sys
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction

• Brand Name: MR Patient Care Expression Model MR400 MRI Patient Monitoring System
• 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: 50907713
• Report Number: 1051786-2026-100071
• Device Sequence Number: 18394815
• Product Code: MWI
• UDI-Device Identifier: 00884838111363
• UDI-Public: (01)00884838111363
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Type of Report: Initial
• Report Date (Section B): 09/26/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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