MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VUE PACS; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number	VUE PACS
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips by swissmedic (ghol-sig-2024-042) that a customer reported that during surgical operation vue pacs was on standby and shutdown, this prevented the surgeon to view the necessary x-ray images for surgery.The system was in clinical use when this occurred.There was no report of harm.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
The manufacturer previously reported that the customer alleged vue client went on standby and shutdown during surgical procedure, this prevented the surgeon from viewing the necessary x-ray images for surgery.User had to re-log back in to vue client.Customer claimed issue created risks for the patient.The investigation revealed that the customer installed vue client with nativebridge component.Vue client was updated to 240 minutes, while nativebridge with its own logout timeout mechanism was not updated to prolong the timeout greater than the default time of 60 minutes.While personnel in the operating room prepare images for orthopedic surgery, nativebridge timed out and prematurely crashes causing vue client to log off.The personnel in the operating room had to log back into vue client, and set the selected images for display, thus causing a brief delay during procedure.The root cause of the issue was due to incomplete synchronization of configuration for logout timeout between three components vue explorer, vue client and nativebridge.No patient harm has been reported by the customer.A review of the instructions for use (ifu) of vue pacs was conducted as part of the investigation into this issue, and it is confirmed that the device was being used within the intended and indicated use of the device.However, post installation of nativebridge, the software configuration between vue client and vue explorer was not tested by the customer.The aid to view images is significant and important, however, the overall delay caused by needing to log back in to vue client system, is negligible for the orthopedic surgery length, and not expected to cause injury.

• Brand Name: VUE PACS
• Common Device Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: trudy kunnen ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 19089524
• Report Number: 3003768277-2024-02183
• Device Sequence Number: 7102593
• Product Code: LLZ
• UDI-Device Identifier: 00884838100336
• UDI-Public: 00884838100336
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: VUE PACS
• Device Catalogue Number: 8986424
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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