MAUDE Adverse Event Report: MERGE HEALTHCARE ICONNECT ENTERPRISE ARCHIVE IMAGE ARCHIVE

Model Number 9.1.2

Device Problem Patient Data Problem (3197)

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

Event Date 07/27/2015

Event Type  Malfunction  

Manufacturer Narrative

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

Event Description

Customer reported that priors are failing to retrieve back to facility image cache (fic) for one patient. The pacs admin retrieved the priors manually. User used qc function to make a change in the data and inadvertently connected the studies to another patient. Further analysis has found that at some point, the customer modified a group of studies on the long term archive (lta) at the site which resulted in the studies being placed under an incorrect patient. (b)(4).

• Brand Name: ICONNECT ENTERPRISE ARCHIVE
• Type of Device: IMAGE ARCHIVE
• 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: 5437880
• MDR Text Key: 38219246
• Report Number: 2183926-2015-00138
• 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

0 PatientS WERE 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: 9.1.2
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/10/2014
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse