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

Model Number	865214
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the customer experienced a critical incident on (b)(6) 2021 where the patient's blood pressure could not be appropriately monitored due to an unspecified monitor failure.The customer then indicated that the patient was removed from the scanner a separate monitor was deployed to monitor the patient.The customer indicated that the patient ultimately passed away after coding in the mri.The customer then indicated that they were experiencing multiple unspecified monitor issues with the current monitors.
Additional Manufacturer Narrative
The means of evaluation is unknown at this time.A philips representative spoke with a clinician and an mri technician at the customer facility.The customer mri technician indicated that the patient was critically ill at the time of the event and that an nibp reading could not be obtained on the mri safe patient or bedside monitor.The customer mri technician indicated that the failure of the nibp reading was not a philips equipment failure, but that the patient was too ill to monitor.The customer indicated to the philips representative that the monitor performed perfectly.Despite multiple attempts, no additional information had been provided to aid in the investigation.This philips representative indicated that the device was working as intended with no failures found.No further investigation or action is warranted at this time.This event was reported as it involved a patient death, with no additional information on how the philips device caused or contributed to that event.As it was determined that the complaint device was functioning as intended, as the patient death was indicated by the customer as being unrelated to a failure of the philips device, this event will not be considered to be a malfunction of the philips device.
Event or Problem Description
It was reported that the customer experienced a critical incident on (b)(6) 2021 where the patient's blood pressure could not be appropriately monitored due to an unspecified monitor failure.The patient was indicated by the customer to have passed away.

• Brand Name: EXPRESSION MRI PATIENT MONITOR
• Common Device Name: EXPRESSION MRI PATIENT MONITOR
• 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: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13011664
• Report Number: 1051786-2021-10079
• Device Sequence Number: 1765875
• Product Code: MWI
• UDI-Device Identifier: 00884838016064
• UDI-Public: 00884838016064
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K090785
• 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

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: 865214
• Device Catalogue Number: 865214
• 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: 11/15/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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