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

Model Number	866120
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2022
Type of Reportable Event	Death
Event or Problem Description
The customer reported that there was a communication failure between the mr200 and ip5 monitor.Patient was reported to have stopped breathing.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that there was a communication failure between the mr200 and ip5 monitor.Patient was reported to have stopped breathing.The device losing connectivity caused a lapse in monitoring of the patient.The philips technical consultant (tc) confirmed the event.The tc was on site and unable to retrieve data logs from the event.The tc confirmed that the communication was lost when the mri door was closed.The customer declined service, but requested an antenna to improve communication.The cause of the event was the loss of connection.It is unknown if the issue was resolved.The device remained on site.
Additional Manufacturer Narrative
Supplemental report submitted with reference to manufacturer's report number 1051786-2022-00047.The reported problem was caused by a lack of communication due to mri door closed and no installed antennas.The customer was aware this was an issue and did not attempt to order any additional antennas until after this event.The cause of the event was the loss of connection due to a lack of installed antennas.It is the customer's responsibility to purchase an antenna through the proper channels.We will consider the customer resolved the issue with purchase of an antenna.The device remained on site.
Event or Problem Description
The customer reported that there was a communication failure between the mr200 and ip5 monitor.Patient was reported to have stopped breathing.The device losing connectivity caused a lapse in monitoring of the patient.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15439767
• Report Number: 1051786-2022-00047
• Device Sequence Number: 20232612
• Product Code: MWI
• UDI-Device Identifier: 00884838033764
• UDI-Public: 00884838033764
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Model Number: 866120
• Device Catalogue Number: 866120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 09/07/2022; 09/07/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/25/2022; 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2021
• 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: 49 YR
• Patient Sex: Male