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

Model Number	11.1.3
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
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) 2020, a customer contacted merge healthcare to inform us that they were unable to view an exam report from a recent exam.Merge healthcare determined upon investigation that the report saved but failed to upload.Logs were reviewed and did not indicate any issue.A blank report document was manually placed in the folder and the report was re-dictated and 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).

• Brand Name: MERGE UNITY PACS
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• MDR Report Key: 10863174
• Report Number: 2183926-2020-00049
• Device Sequence Number: 11413427
• Product Code: LLZ
• UDI-Device Identifier: 00842000100058
• UDI-Public: (01)00842000100058(10)11.1.3.16683(11)190626
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 11/18/2020

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: 11.1.3
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/18/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2019
• 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: Reuse
• Patient Sequence Number: 1