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

Model Number 866389

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/17/2024

Event Type  malfunction  

Event Description

The customer reported that multiple philips patient information center ix (pic ix) surveillance telemetry monitoring central stations were down and this affected multiple systems being down.More than half of the system were offline; out of 19 switches only three switches were online, and various floors had to be rebooted.The device was in clinical use at the time the issue was discovered; there was no adverse event or patient harm reported.

Manufacturer Narrative

A philips remote service engineer (rse) obtained some details via troubleshooting performed.The rse indicated that many distribution (dist) and access switches showed offline and were not ping-able from the core router.Core router does not show them in cisco discovery protocol (cdp) neighbor output.The rse advised the customer biomedical engineer (biomed) to reboot the distb devices on various floors and the philips patient information center ix (pic ix) surveillances reconnected.The rse logged into dista's and saw that the uplinks were error-disabled due to loopback.The biomed was able to restart the remaining switches, and all surveillances were back online.A philips field service engineer (fse) went onsite for root cause analysis and determined that some units were having disconnections from the primary server due to fiber ports in the error disabled state.Corea: port 2 was in down status ,re-enabled port 25 on g412dista switch.Port 6 was in down status , re-enabled port 25 on g267dista switch.Core b: port 3 was showing unstable connection, changed port from 25 to 28 on 1114distb switch.The fse recommended to re-certify/test fiber runs specifically for: - g412dista, g267dista, 1114distb, switches and monitor/observe fiber connection status on the cores.Based on the information available and the testing conducted, the cause of the reported problem were disconnections from the primary server due to fiber ports in the error-disabled state.The reported problem was confirmed.The affected ports were enabled by the engineer by performing a system reboot and reconnection was reestablished.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: 19018055
• MDR Text Key: 339095455
• Report Number: 1218950-2024-00228
• 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,Company Representative
• 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: 03/17/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• 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