MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE ICONNECT ENTERPRISE ARCHIVE; DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM

Model Number ICONNECT ENTERPRISE ARCHIVE V

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare investigated the customer's allegation.Based on the information and logging data that was gathered, information suggests that the incorrect patient name was sent from the imaging modality to the merge healthcare device.Merge healthcare (b)(4) archive accepts data from the modalities that are sent by users.This issue appears to be a user error that occured at the modality.

Event Description

Merge (b)(4) consolidates, standardizes and archives dicom and non-dicom images and data from disparate pacs, specialties and sites.(b)(4) works with merge radsuite which is an application that provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.The system displays traditional 2d and reconstructed 3d radiological images using web-enabled viewers over both local and wide area networks.On (b)(6) 2016 a customer reported to merge healthcare support that the name on a patient's study had changed.The issue was readily apparent to the user due to the workflow at the site is to have the techs check in radsuite that the paperwork attached to the study is correct.During this process the customer noticed that the name was different than expected.With an incorrect name appearing on a patient's report there is a potential for an incorrect diagnosis and/or treatment.However, the customer did not allege any patient injury as a result of this issue.(b)(4).

• Brand Name: MERGE ICONNECT ENTERPRISE ARCHIVE
• Type of Device: DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53066
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: mike diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123750
• MDR Report Key: 6244625
• MDR Text Key: 65056612
• Report Number: 2183926-2017-00012
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K05328124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 12/12/2016

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?: No
• Device Operator: No Information
• Device Model Number: ICONNECT ENTERPRISE ARCHIVE V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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