MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION PATIENT MONITOR (MR200)

Model Number	866120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer want to have an investigation on the device.The device was in use at time of event.A patients death was reported.
Additional Manufacturer Narrative
After further investigation this complaint is deemed no longer a reportable event.It was reported the device presented with the following: request for equipment check the customer stated that they requested a investigation of the device.During the investigation of the device at the customer's site, the customer's mri technician in charge, confirmed that the device was not responsible for or contributed to the reported death.After conducting a comprehensive inquiry, it was concluded that the pacemaker malfunction was not linked to any issues with phillips equipment.The philips field service engineer confirmed that the philips device is working as expected.

• Brand Name: EXPRESSION PATIENT MONITOR (MR200)
• Common Device Name: EXPRESSION PATIENT MONITOR (MR200)
• 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: hisham alzayat ; 12151 research parkway; orlando, FL 32826 ; 4072753220
• MDR Report Key: 16666285
• Report Number: 1051786-2023-00003
• Device Sequence Number: 14945516
• Product Code: MWI
• UDI-Device Identifier: 00884838033764
• UDI-Public: 00884838033764
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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?: Yes
• Device Model Number: 866120
• Device Catalogue Number: 866120
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 04/14/2023
• 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 Sex: Unknown