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

Model Number 866389

Device Problem Application Network Problem (2879)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 318962975
• Report Number: 1218950-2023-00483
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: 00884838104594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• 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
• Device Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1