MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number	866389
Medical Device Problem Code	Application Network Problem (2879)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
A customer biomedical engineer (biomed) reported that all of patient monitoring keeps rebooting and disconnecting from server in all floors and departments.The biomed called back and spoke to a philips remote service engineer (rse); some of servers and switches for multiple departments are still not working or is intermittently.An additional follow-up call indicated the site was running according to the biomed.The cause of the issue is unknown and hospital information technology (it) is also working with philips on the issue.Further information will be reviewed to determine the root cause.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
The site had a philips field service engineer (fse) visit on 23jun2023.It was found that the server became unreachable on the customer supplied clinical network (cscn).Based on the information available and the testing conducted, the cause of the reported problem was due to the customer network disconnecting from the server.Cscn issues are not considered a reportable event, as this is not considered a philips product.The investigation concludes that no further action is required at this time.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• 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: 17301639
• Report Number: 1218950-2023-00483
• Device Sequence Number: 7061366
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: 00884838104594
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K211900
• 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,Company Representative
• 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: 866389
• Device Catalogue Number: 866389
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2017
• 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