MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION PATIENT MONITOR (MR400)

Model Number	866185
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The biomed department of the hospital spoke with philips representatives who provided specifics on where to position the patient and mr400 modules to mitigate the issue.The customer was contacted for additional information regarding clarification of the allegation, cause of the issue, and patient impact, but no additional information was provided.Based on the information available and the testing conducted, the cause of the reported problem is unknown.
Event or Problem Description
It was reported that during an mri scan of a neonate, there were multiple instances of signal interference and incorrect vital sign readings.This issue resulted in the nurses initiating chest compressions to follow safety protocol.It is unknown if the device was in use at time of the event.There was a report of patient or user harm.

• Brand Name: EXPRESSION PATIENT MONITOR (MR400)
• Common Device Name: EXPRESSION PATIENT MONITOR (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: hisham alzayat ; 12151 research parkway; orlando, FL 32826 ; 4072753220
• MDR Report Key: 18318808
• Report Number: 1051786-2023-00013
• Device Sequence Number: 7026056
• Product Code: MWI
• UDI-Device Identifier: 00884838039131
• UDI-Public: 00884838039131
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Other Health Care Professional
• Type of Report: Initial

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: 866185
• Device Catalogue Number: 866185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2023
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2022
• 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: Required Intervention
• Patient Sex: Unknown