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

Model Number 866389

Device Problem Wireless Communication Problem (3283)

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

Event Date 03/23/2024

Event Type  malfunction  

Manufacturer Narrative

Philips remote service engineer (rse) spoke to the customer and determined that the device status showed both routers for tuscon main and several network switches offline: 1190_corea (10.112.192.2) and 1190_coreb (10.112.193.3).A field service engineer (fse) was dispatched for onsite support.The fse found that the core routers had maximum utilization on multiple cores, and event logging lines were present.The fse determined the access switch was flapping.The fse went to the main distribution frame (mdf) closet and discovered that router cores a and b were high central processing unit (cpu) utilization.The fse restarted router cores a and b and eliminated the three "logging event" lines from trunks on all psn switches.Although there was a reduction in the cpu utilization of router cores a and b, it was discovered that several switches, and the access point (ap) were offline.The fse checked all the switches and looked through each intermediate distribution frame (idf) closet.Each of the idf closets err-disable ports issue was resolved, and the system began to function normally again.The fse discovered several switches with only one connection and 2 switches that were offline.The fse fixed all links and got all switches back online.It was determined the cause of the reported problem was the cisco switches.The device was operational after configuration changes were made.It was recommended that the cores be eventually upgraded to 16.6.8.The investigation concludes that no further action is required at this time.

Event Description

Philips received a complaint on the patient information center ix indicating that the picix hosts in the main tuscon campus were in local mode and not monitoring patients.The device was in clinical use.There was no patient or user harm or injury reported.

• 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: 19059809
• MDR Text Key: 339700906
• Report Number: 1218950-2024-00247
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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: 03/23/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• 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