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

Model Number	865214
Medical Device Problem Codes	Incorrect Measurement (1383); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to the front-line agent that there was a communication problem with the device and that the vitals coming over are incorrect.Additional information about the incorrect vitals was requested from the customer multiple times, but no further information has been received.There was no reported patient or user impact.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported to the front-line agent that there was a communication problem with the device and that the vitals coming over are incorrect.According to the philips field service engineer (fse), the issue was related to communication of the monitoring system and this contributed to inaccurate readings when they were comparing the readings to their transport monitor.Additional information about the incorrect vitals was requested from the customer multiple times, but no further information was received.There was no reported patient or user impact.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15192333
• Report Number: 1051786-2022-00040
• Device Sequence Number: 5633686
• Product Code: MWI
• UDI-Device Identifier: 00884838016064
• UDI-Public: 00884838016064
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• 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?: 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2012
• 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
• Patient Sex: Unknown