MAUDE Adverse Event Report: Philips Medical Systems Nederland B.V. Vue PACS; System, Image Processing, Radiological

Model Number	Vue PACS
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received a complaint indicating that the user was unable to access site examinations.Consequently, the user was unable to interpret a scanner for a patient.The patient deteriorated and critically damaged his health status.The customer called an interpretation urgently with a 3rd party company.
Additional Manufacturer Narrative
The company has initiated an investigation into the event.The investigation is currently in progress.A follow-up report will be filed with additional details once the investigation is complete.

• 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: edita reznik-shmueli ; 3000 minuteman rd; andover, MA 01810 ; +1(617)245-5900
• MDR Report Key: 50083162
• Report Number: 3003768277-2026-101287
• Device Sequence Number: 10719507
• Product Code: LLZ
• UDI-Device Identifier: 60889971047809
• UDI-Public: (01)60889971047809(10)V12.1.5.1
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Vue PACS
• Device Catalogue Number: 1149418
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/11/2026
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown