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

Model Number UNITY PACS R11.1.2.2

Device Problem Computer Software Problem (1112)

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

Event Date 02/22/2017

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.In this work flow, the dictation was created by the physician.The transcriptionist attempted to open the dictation to type the report, no dictation was available.Merge healthcare is continuing to further investigate the allegation from the customer to determine if any corrections or corrective actions are necessary.

Event Description

Merge unity pacs 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) 2017, a customer contacted merge healthcare support and alleged that an exam report was saved but the transcriptionist was unable to open the dictation to type up the report.Merge technical support investigated the customer's allegation and determined that the unity exam audit has information related to the report's save event.As a result of not being able to find the dictation, the reading physician re-read the exam to resolve the issue.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.(b)(4).

Manufacturer Narrative

Unity investigation showed the database was updated but the report did not upload to the server.Audit trail showed the exam was read and saved.The exam was re-read by the physician.Logs were unavailable for review as this issue was discovered after they truncated on the station.No further review/investigation will be performed for cause.

• 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: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029
• MDR Report Key: 6419805
• MDR Text Key: 70427599
• Report Number: 2183926-2017-00075
• 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,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS R11.1.2.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• 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