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

Model Number ICONNECT ENTERPRISE ARCHIVE 9.40

Device Problem Computer Software Problem (1112)

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

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

Upon investigation, it was found studies were overwritten from merge pacs to the ea from a migration completed in 2013.The result of the studies being overwritten was due to user error by the support tech completing the migration.At this time, the investigation is complete and no further actions are required.

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.A customer reported they were unable to retrieve a study from iconnect enterprise archive (ea).It was found this study was overwritten from merge pacs to the ea system during a migration in 2013.The study is no longer available to be viewed.This may potentially cause a delay in treatment but is unlikely to cause harm as there is other clinical information that will be utilized to support the treatment of the patient.(b)(4).

• Brand Name: ICONNECT ENTERPRISE ARCHIVE
• Type of Device: DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland, wi 53029, WI 53029
• Manufacturer Contact: mike diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6227817
• MDR Text Key: 64015001
• Report Number: 2183926-2017-00006
• 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: Other
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICONNECT ENTERPRISE ARCHIVE 9.40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2014
• 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