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

Model Number	866389
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
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
It was reported that there is a hospital wide outage of the patient information center ix (pic ix) connections to the network.The device was in use on a patient at the time of the event.There was no adverse event reported.A philips remote service engineer (rse) spoke with the customer and learned that all hosts and servers were showing "unknown" status.The system was completely offline.The rse noticed that there is ping and the domain name server (dns) seemed to be working, but the system was showing as disconnected.The rsw worked with network engineers to connect with the customer's team.A check of the service logs found network connectivity errors.Rebooted the primary server and all the hosts and servers came back online.A philips technical consultant (tc) was dispatched and the device logs were collected.The customer has requested a root cause analysis.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with the customer and determined that all hosts and servers were showing an unknown status and clinical staff were monitoring patients locally.The rse worked with philips network engineers to further investigate the issue.Service logs found network connectivity errors.A check for the continuous integration (ci) master found that no ci master was elected for three mutlicast zones.The primary server underwent a reboot and all hosts and servers came back online.A philips field service engineer (fse) was dispatched.Logs were retrieved and the issue was escalated to the national support service (nss) for further investigation.The logs showed that the customer was conducting vmware snapshots (a short-term image of a vm [virtual machine] that preserves the power state and data files) and full vm backups.This is not compatible with the philips network.The cause of the reported problem was vmware snapshots and full vm backups conducted by the customer it.The reported problem was confirmed.The device was operational after the primary server was rebooted.The customer it was advised to discontinue vmware snapshots and full vm backups to prevent recurrence of this issue.

• 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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19629871
• Report Number: 1218950-2024-00473
• Device Sequence Number: 15303849
• Product Code: MHX
• UDI-Device Identifier: 00884838112070
• UDI-Public: (01)00884838112070
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 06/03/2024
• Supplement Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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