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

Model Number	865214
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the spo2 readings were high.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

• 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
• MDR Report Key: 11655538
• Report Number: 1051786-2021-10005
• Device Sequence Number: 11664278
• Product Code: MWI
• UDI-Device Identifier: 00884838016064
• UDI-Public: 00884838016064
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K090785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Distributor Facility Aware Date: 03/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1