MAUDE Adverse Event Report: MERGE HEALTHCARE ICONNECT ENTERPRISE ARCHIVE; ARCHIVER

Model Number 10.0.2

Device Problem Device Issue (2379)

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

Event Date 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.Development assessed and implemented a fix at the customer site.Customer reported no longer seeing the error message.

Event Description

Iconnect enterprise archive a vendor neutral archive for storage and communications of medical images and data.A customer was migrating from radsuite to merge pacs.During the migration, image load errors were occurring on studies after the half folder tool was ran.Customers migrating from radsuite to merge pacs will see this issue for any data stored prior to iconnect enterprise archive version 8.X.This issue causes image load errors in the pacs viewer preventing a user from viewing priors.The customer did not report a serious injury to the patient.(b)(4).

• Brand Name: ICONNECT ENTERPRISE ARCHIVE
• Type of Device: ARCHIVER
• 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 rd; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437905
• MDR Text Key: 38227896
• Report Number: 2183926-2016-00002
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NONE, EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10.0.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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