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

Model Number	VUE PACS
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips by swissmedic (ghol-sig-2024-055) that a customer reported that vue pacs displays patient x, but when double-clicked patient y appears in the worklist.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 that vue pacs displayed patient x, but when double-clicked, patient y appeared in the worklist.Customer claimed patient safety risk due to getting the wrong images of the patient.The investigation revealed in the sequence of events that the customer has opened and closed a few selected names in vue explorer.After random number of patients review, a new selection is made with the double-click action on a series.Vue explorer then occasionally loaded another patient information to be reviewed instead of the new patient selection.This issue was detected by the customer and there were no reports of patient harm.The root cause of the issue was due to a software defect that was caused by a race condition, where the double-click code event arrived before the selection code event.That caused execution of the double-click on the previous selection even though this is not the item clicked.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 (to load an entire study from the list of studies pane or series thumbnails pane: double-click on the study).Considering the standard practice of care, a physician would verify the patient information and determine the presented information is of another patient; therefore, there would be no reasonably foreseeable risk of harm of a misdiagnosis of patient condition.Desired patient name remains on the worklist, available to open next, so no delay in care or diagnosis.

• 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: 19088522
• Report Number: 3003768277-2024-02179
• Device Sequence Number: 7141167
• 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: 04/11/2024
• 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