MAUDE Adverse Event Report: MERGE HEALTHCARE ICONNECT ENTERPRISE ARCHIVE; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL

Model Number ICONNECT ENTERPRISE ARCHIVE V11.1.2

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is continuing to investigate and evaluate the customer's allegation that images were not available for the patient.When additional information becomes available a supplemental report will be submitted.

Event Description

(b)(6) is a web-based solution that provides a conduit for a piece of software to reach the greatest number of platforms.The system is designed to provide workflow integration capabilities for healthcare enterprises.On 06/26/2017, merge healthcare received information that images were not available for a patient.Additional information was received from the account on 07/24/2017 that indicated the inability to view images impacted the patient's care.A procedure was delayed due to the inability to view previously acquired images.The patient was re-imaged and the procedure was completed without issue.With images not being available for viewing as expected, there is a potential for harm due to a delay in treatment.The customer indicated that no direct patient harm occurred as a result of the delayed procedure.Reference complaint number (b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 07/26/2017.It has been found that this study is not present on the cardio fic or the lta.Engineering's findings indicate the study did not successfully route to the lta ((b)(4)) before it was deleted from the fic by the deletor process.The cas has no entries for this study in the database table which stores the locations of images.The cas will remove an entry in the table when a study is deleted on the fic.For this particular study, because the cas does not have database entry for the study on the lta, this further confirms that the study did not successfully route to the lta.The fic's deletor vetoer configurations at the time of this study were set to only check whether the study was on the router table, and if not, it was eligible for deletion.Typically the deletor vetoers are also configured to check whether a study is present on the lta before deleting, however this vetoer was not configured due to human error when deletor was turned on in 2012.The vetoer was enabled in june of 2017.When the study failed to store to the lta, it appeared on the routerwork table as a failed object.The routerwork table has configurations to remove failed objects after a set period of time, which had happened for this study.With the misconfiguration of deletor, the study was eligible for deletion because it was not present on the routerwork table and the check was not in place to verify if the study was on the lta.Revised information contained in this supplemental report includes the following: h6 - evaluation codes: results code: 3238 software installation problem.Conclusions code: 19 human factors issue.H10 - indication of additional manufacturer information is contained in this follow-up report.

• Brand Name: ICONNECT ENTERPRISE ARCHIVE
• Type of Device: DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, WI 53029
• MDR Report Key: 6745980
• MDR Text Key: 81431681
• Report Number: 2183926-2017-00160
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• PMA/PMN Number: K05328124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICONNECT ENTERPRISE ARCHIVE V11.1.2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1