MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION INFORMATION PORTAL (IP5)

Model Number	865471
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that since last week, the customer was reporting an issue with the touch screen.It was alleged that intermittently, the touch screen hangs and the user cannot perform any task.The only option was to restart the ip5.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.
Event or Problem Description
It was reported that since last week, the customer was reporting an issue with the touch screen.It was alleged that intermittently, the touch screen hangs and the user cannot perform any task.The only option was to restart the ip5.The customer indicated that a touch calibration had been performed three times and the device passed every time.The ip5 supply was removed for two minutes and restarted.That action resolved the issue, but the screen later hung again.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.
Additional Manufacturer Narrative
A philips response service engineer (rse) spoke to the customer.The rse evaluated the touch screen behavior of the complaint device and the customer was advised to replace the unit.The unit was replaced as a resolution.

• Brand Name: EXPRESSION INFORMATION PORTAL (IP5)
• Common Device Name: EXPRESSION INFORMATION PORTAL (IP5)
• 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: 13550944
• Report Number: 1051786-2022-00014
• Device Sequence Number: 5269315
• Product Code: MWI
• UDI-Device Identifier: 00884838031890
• UDI-Public: 00884838031890
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K212227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• 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: 865471
• Device Catalogue Number: 865471
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2018
• 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