MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MR PATIENT CARE PORTAL 5000

Model Number	866162
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the device freezes during a case and has to be restarted.The device was in use on patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
A philips field service engineer (fse) went onsite to evaluate the device in question.The fse indicated during an evaluation of the system that the portal 5000 locks up periodically the screen freezes and requires a power cycle to bring it back up.The philips field service engineer (fse) swapped out the touchscreen monitor and tested the settings.The device was operational after repairs were completed and the device was returned to the customer.The investigation concludes that no further action is required at this time.

• Brand Name: MR PATIENT CARE PORTAL 5000
• Common Device Name: MR PATIENT CARE PORTAL 5000
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18318462
• Report Number: 1051786-2023-00012
• Device Sequence Number: 20402936
• Product Code: MWI
• UDI-Device Identifier: 00884838091948
• UDI-Public: 00884838091948
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: 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: 866162
• Device Catalogue Number: 866162
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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