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

Model Number MERGE ICONNECT ENTERPRISE ARCHIVE

Device Problem Missing Test Results (3267)

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

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is continuing to investigate this customer's issue to determine if any corrections or corrective actions are necessary.

Event Description

Iconnect enterprise archive is a web-based solution that provides a conduit for a piece of software to reach the greatest number of platforms.The system is designed to provide workflow integration capabilities for healthcare enterprises.On (b)(6) 2016 a customer alleged that "when viewing studies the first image is missing.This happens on either thick client or web viewer, intermittently, for studies that came from acquisition group lincoln, which is sending to the main fic." there is a potential for delay in patient diagnosis or treatment and a potential for harm to the patient if there are missing images.However, there was no delay in patient diagnosis or treatment reported by the customer.There was no harm to the patient reported by the customer.Reference complaint number (b)(4).

Manufacturer Narrative

Mdr 2183926-2016-00770-001 ((b)(4).) this supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted (b)(6) 2016.During troubleshooting efforts between the customer and merge technical support, it was found that procedures can be performed, however the customer reported that the first image is missing when viewing images and that this happened on either thick client or web viewer, intermittently, for studies that came from acquisition group lincoln, which is sending to the main fic.There was no delay in patient diagnosis or treatment reported.There was no harm or potential harm to the patient reported.Per support, for the three examples provided by the customer in the case record, there is a database entry for the sop, however there is no corresponding file in the file system.If cardio attempted to view these studies, the archive would not be able to provide the sop as is does not exist on the file system where expected.Support ran disk to database integrity checks to see if there are any orphaned files.Missing image is not present for all three studies.Integrity checks did not show orphaned file.Revised information contained in this supplemental report includes the following: g1-2 - updated contact office - name/address g4 - date new information received by manufacturer, g7 - indication that this is follow-up report 001, h1 - indication of malfunction as reportable event, h2 - indication of additional information and device evaluation, h3 - indication that the device evaluated by manufacturer, the device was not evaluated by manufacuturer.H6 - evaluation codes, conclusion code 67: no problem detected.H10 - indication of additional manufacturer information is contained in this follow-up report.

• Brand Name: ICONNECT ENTERPRISE ARCHIVE
• Type of Device: DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 6111882
• MDR Text Key: 60282000
• Report Number: 2183926-2016-00770
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• PMA/PMN Number: K05328124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MERGE ICONNECT ENTERPRISE ARCHIVE
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1