MAUDE Adverse Event Report: MERGE UNITY PACS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number	12.0.6
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Merge unity pacs is a medical image and information management system that is used for viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.On (b)(6) 2021, a customer contacted merge healthcare support to report that a patient report was inaccessible.Merge healthcare technical support determined upon investigation that the report saved but failed to upload.Logs were not available for review.A blank report was put in place by merge healthcare technical support and the report was subsequently viewable as expected.No further action is necessary at this time.This has the potential to delay patient treatment and/or diagnosis.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).
Additional Manufacturer Narrative
This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 9/10/2021.As of 9/13/2021, merge healthcare is ceasing reporting on merge unity pacs report failures to upload.The issue in question presents when a report is read and notes dictated by a clinical user but the dictation/reading fails to upload and is lost.This issue is caused by network issues and not caused by or contributed to by merge unity pacs in any way.Review of this issue based on current knowledge of the device, clinical workflow, existing mitigations against user errors, and the presence of no death or injury associated with the issue at any point between 2016 and 2021 indicates that the device is operating as designed and that this issue presents remote likelihood of injury or harm to a patient.No further action is required.

• Brand Name: MERGE UNITY PACS
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• MDR Report Key: 12457090
• Report Number: 2183926-2021-00028
• Device Sequence Number: 17160595
• Product Code: LLZ
• UDI-Device Identifier: 00842000100744
• UDI-Public: (01)00842000100744(10)12.0.6(11)200828
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K041935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 12.0.6
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 09/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2020
• 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