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

Model Number UNITY PACS R11.0.3

Device Problems Device Issue (2379); Loss of Data (2903)

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

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is further investigating the allegation from the customer to determine if any corrections or corrective actions are necessary.

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) 2016 a customer alleged that they were unable to find a patient's report however, the patient's exam was found.Merge healthcare assisted the customer and determined that the customer's exam was done on (b)(6) 2016.While the customer indicated that the exam had been reviewed and a report created, no report was located.Therefore the physician had to re-read the exam.With a report not being found within merge unity pacs as expected, there is a potential for a delay in treatment or diagnosis which can lead to harm.There was no reported adverse event to a patient due to this issue.(b)(4).

Manufacturer Narrative

The jira for this issue is open and active.On (b)(6) 2018 (b)(6) had conversation with the pacs administrator.The pacs admin reports they have migrated to a new pacs system and are no longer reading/acquiring on unity, therefore they will not be upgrading software when the jira is resolved.No further review/investigation of this complaint will be performed.

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE AND ARCHIVING AND 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 ; 2629123570
• MDR Report Key: 5835486
• MDR Text Key: 50815914
• Report Number: 2183926-2016-00669
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS R11.0.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2016
• 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