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

Model Number	MERGE UNITY PACS R11.2.1
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Merge unity pacs is designed to display a message to the user when an exam report fails to upload to the image server.In this instance, there was no evidence that the physician received the message warning that the report did not upload.It was not possible to determine if the message displayed on the screen for the physician when the report was first read and saved.Troubleshooting from unity support found that there was a reported generated, however the document was not uploaded to i:\ drive.A new word document was created and renamed reported.Audit trail showed the exam was read, approved and saved.Pending further review.A supplemental report will be provided.
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 december 13, 2018 the customer reported an exam was completed, however, there is no exam report.An investigation showed the report did not upload successfully and had to be read again by the doctor.The exam was read, there was an upload error at the time of the save event.There was no reported adverse event to a patient.A missing report does have the potential to delay patient care.(b)(4).
Additional Manufacturer Narrative
Troubleshooting from unity support found that there was a reported generated, however the document was not uploaded to i:\ drive.A new word document was created and renamed reported.Audit trail showed the exam was read, approved and saved.Follow up with the site indicated that the issue was confirmed to be resolved.Revised information contained in this supplemental report includes the following: date new information received by manufacturer (case closure date).Indication that this is follow-up report 001.Indication of malfunction as reportable event.Indication of additional information.Device codes: methods code: 10 - testing of actual/suspected device.Results code: 104 - software problem, 4215 - data storage or loss of data.Conclusion code: 4309 - caused traced to environment.Indication of additional manufacturer information is contained in this follow-up report.

• Brand Name: MERGE UNITY PACS
• Common Device Name: PICTURE ARCHIVING COMMUNICATIONS SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 8207334
• Report Number: 2183926-2018-00105
• Device Sequence Number: 19308490
• Product Code: LLZ
• UDI-Device Identifier: 00842000100331
• UDI-Public: 00842000100331
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K041935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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: MERGE UNITY PACS R11.2.1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/01/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1