MAUDE Adverse Event Report: Philips North America LLC 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 Codes	Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent mri scan with use of phillips expression mr400 mri patient monitoring system.After the mri, he was noted to have a left chest wall burn.Plastic surgery noted a full thickness chest wall burn that later required surgical debridement and split thickness skin grafting.Manufacturer response for monitor,physiological,patient(without arrhythmia detection or alarms), expression mr400 mri patient monitoring system (model mr400) (per site reporter).Provided with ifu changes from "[redacted]"-last year not shared with "[redacted]"-our hospital when published.

• Brand Name: Expression MR400 MRI Patient Monitoring System (Model MR400)
• Common Device Name: MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): Philips North America LLC; 222 jacobs street; cambridge MA 02141
• MDR Report Key: 50914635
• Report Number: 50914635
• Device Sequence Number: 20169626
• Product Code: MWI
• UDI-Device Identifier: 00884838039131
• UDI-Public: (01)00884838039131
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/03/2026
• Report Date (Section F): 09/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• 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
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Male
• Date Report Sent to FDA: 09/03/2026