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	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that while monitoring a sedated patient, the clinical staff noticed a "co2 hardware error" message.Then, the patient was unable to be monitored and staffed noticed that the patient was non-responsive.The patient died, as attempts to revive the patient by the clinical staff were unsuccessful.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
Additional Manufacturer Narrative
Philips is in process of obtaining additional information.A follow-up report will be submitted upon completion of the investigation.

• 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 ; +1(407)275-3220
• MDR Report Key: 50866242
• Report Number: 1051786-2026-100065
• Device Sequence Number: 21511558
• Product Code: MWI
• UDI-Device Identifier: 00884838039131
• UDI-Public: (01)00884838039131
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/23/2026

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: 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: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 39 YR
• Patient Sex: Unknown
• Patient Weight: 300 LB