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

Model Number 9.40

Device Problems Computer Software Problem (1112); No Display/Image (1183)

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

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Site reported there is a study that is archived but cannot be opened in iconnect access.The user was unable to send the study over to pacs with 131 images in the study.The following scenario would result in this issue: user requests deletion of a particular image and it invokes the staging process which: pulls the entire study from tier 2 to tier 1.Updates the storage partition id (of the study table) with the staged partition id (that was [?]null' earlier).It then proceeds to execute the following sequence of operations generally: delete image staged in tier 1.Clear the corresponding database image entries (in tier 1).Delete the tier 2 tar.Clear the study location table entry.However, when the deletor got fired to query for the images, before the study location table entries are cleared (before step 4 mentioned above), the corresponding study again becomes eligible for deletion.The reason is that last staged date/time is yet to be updated in the study location table.(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: 5439843
• MDR Text Key: 38288368
• Report Number: 2183926-2015-00147
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/16/2016

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: 9.40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• 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
• Removal/Correction Number: 2183926-02/15/2016-062-C
• Patient Sequence Number: 1