MAUDE Adverse Event Report: GE HEALTHCARE CENTRICITY PACS; PICTURE ARCHIVING COMMUNICATION SYS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No gehc product defect was identified.The issue was determined to be use error, where the ed physician did not notice the system's configuration was set to display comparison images.They overlooked several indicators, including the bold white corner brackets, the viewport header with the date/time of the study, and the image overlay with the date/time of the study, all of which signaled that the image was a comparison.Gehc has since conducted customer retraining.
Additional Manufacturer Narrative
Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.Block a: patient information was not provided.Legal manufacturer: hcit chicago - 500 west monroe usa chicago il 60661.
Event or Problem Description
Ed physician reviewed chest x-ray on centricity pacs - ra1000 clinical workstation with include comparison enabled.Physician did not recognize chest x-ray image was a comparison and treated patient for a pneumothorax from an old comparison chest x-ray by placing a chest tube into lung.Patient's current chest x-ray was normal (no pneumothorax). pacs admin reports no other patient impact.

• Brand Name: CENTRICITY PACS
• Common Device Name: PICTURE ARCHIVING COMMUNICATION SYS
• Manufacturer (Section D): GE HEALTHCARE; 500 west monroe; chicago IL 60661
• Manufacturer (Section G): GE HEALTHCARE; 500 west monroe; chicago IL 60661
• Manufacturer Contact: michele marousek ; 500 w monroe; chicago, IL 60661
• MDR Report Key: 20789000
• Report Number: 3004526608-2024-00001
• Device Sequence Number: 20566244
• Product Code: LLZ
• UDI-Device Identifier: 00840682145558
• UDI-Public: (01)00840682145558(10)70P0205824366001
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K110875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown