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

Model Number 9.10

Device Problems Computer Software Problem (1112); Application Program Problem (2880)

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

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The site experienced slowness due to the server continuously attempting to route objects to the peer system that were failing to store.Once these objects were identified and placed on hold the slowness stopped and the site could function normally.Further investigation found that the objects failing to route were missing pixel data.Prior to ea 9.4, the archive would allow successful storing of objects with no pixel data.Images containing no pixel data could have originated from outside the ea or, in a certain scenario, internal to the ea.During a store operation the header information is received first and stored to disk.If any transfer syntax conversion is performed, and during that conversion a network abort occurred, the archive would close the file with only the header information it had received in the beginning of the operation.Since the association was aborted, there was no communication channel available to the source to alert them of error and no cleanup of the partial record.This resulted in objects in the archive with no pixel data and only header information.

• 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: 5437890
• MDR Text Key: 38226748
• Report Number: 2183926-2015-00136
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053281
• 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: 02/15/2016

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: 9.10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-02/15/2016-059-C
• Patient Sequence Number: 1