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

Model Number UNITY PACS 11.0.5

Device Problems Computer Software Problem (1112); Loss of Data (2903)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2018

Event Type  malfunction  

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.The exam audit trail did not show a saved report event.It was not possible to determine if the error message displayed on the screen for the doctor when the report was first read and saved notified the failure to upload.There was no evidence that report was saved.The unity support technician's investigation showed that the report was not uploaded and saved.As a result of finalized report being unavailable, the exam was re-read by a physician.No other review/investigation will be performed for cause.

Event 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) 2018, the customer reported that the exam was stuck and the report was not available.Merge technical support investigated the customer's allegation by reviewing the merge unity pacs workstation.The audit trail of the exam showed the original exam was read on the same day as the exam date (b)(6) 2018 however the user did not save the report and that there was no save report event on (b)(6) 2018 in the log.There was no data uploaded and therefore the report was not available.The exam was required to be re-read by the physician.The exam was re-read on (b)(6) 2018.While images are available, a finalized report not being available for subsequent review by the patient's physician could potentially result in a delay in care that could lead to harm.However, the customer did not allege any harm, serious injury or death as a result of this issue.Reference complaint number: (b)(4).

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: meg mucha ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123514
• MDR Report Key: 7632783
• MDR Text Key: 112472704
• Report Number: 2183926-2018-00054
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2018

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
• Device Operator: Health Professional
• Device Model Number: UNITY PACS 11.0.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1