MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS; PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ

Model Number UNITY PACS R11.1.2.7

Device Problem Loss of Data (2903)

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

Event Date 12/05/2018

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.In this instance, there was no evidence that the physician received the message warning that the report did not upload.The merge healthcare unity technician's investigation showed that a save event did occur in the audit trail.However, the read report itself failed to upload properly.To resolve this issue, the exam was re-read by the physician.No other review/investigation will be performed for cause.(b)(4).

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 a customer reported an exam report failed to upload.The merge healthcare, unity technician's investigation showed that a save event did occur in the audit trail.However, the read report itself failed to upload properly.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 (b)(4).

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ
• 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 ; 2629123570
• MDR Report Key: 8202528
• MDR Text Key: 131719254
• Report Number: 2183926-2018-00102
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100058
• UDI-Public: 00842000100058
• 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: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/05/2018

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 R11.1.2.7
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2018
• 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