MAUDE Adverse Event Report: MERGE HEALTHCARE ICONNECT ACCESS; PACS IMAGE VIEWER

Model Number 3.0

Device Problem Patient Data Problem (3197)

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

Event Date 09/20/2012

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Iconnect access displayed incorrect priors report(s) in the viewport area only when more than one prior study (2 or more) was viewed.No injuries were reported.On the study history tab where the prior studies are listed, the correct priors report was always displayed on clicking the study name.The issue happened only in the viewer.There is only one complaint reported so far, over the deployment period from (b)(6) 2012 (iconnect access 3.0 release) until the present.The lone complaint was not reported from an actual clinical user.It was encountered by a pacs administrator at a merge customer site while evaluating the system in preparation for an upcoming go-live.

Manufacturer Narrative

Submitting this supplemental report to add reported fda correction and removal report number.Please note the fda reference numbers are z-0611-2017; res 75497.

• Brand Name: ICONNECT ACCESS
• Type of Device: PACS IMAGE VIEWER
• 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: 5339700
• MDR Text Key: 34886665
• Report Number: 2183926-2015-00114
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-01042016-30-C
• Patient Sequence Number: 1