MAUDE Adverse Event Report: MERGE HEALTHCARE ICONNECT ENTERPRISE ARCHIVE; EA LMB DEVICE DIGITAL IMAGE STORAGE

Model Number ICONNECT ENTERPRISE ARCHIVE V10.0.2

Device Problem Output Problem (3005)

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

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is continuing to investigate the customer's issue to determine if any corrections or corrective actions are required.Does not apply to software.

Event Description

Merge iconnect enterprise archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.Iconnect enterprise archive provides workflow integration capabilities for healthcare enterprises on (b)(6) 2017, a customer contacted merge healthcare alleging that two (2) studies were missing and could not be pulled from the archive.Merge healthcare technical support is investigating the customer's allegation.An analysis of the potential sources and storage of the studies and any other potentially related studies is ongoing.Due to studies not being able to be found as expected, there is a potential for a delay in patient treatment or diagnosis or patient harm.However, there were no reports of delays in patient treatment or diagnosis.At this time there are no reports of patient harm.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 03/15/2017.Merge healthcare conducted an internal investigation (b)(4) to address the customer's reported issue.During troubleshooting efforts between merge healthcare and the customer, it was noted that the studies in question had been uploaded by the customer to pacs via cd and then transferred to ea (enterprise archive).These studies were to be used by a provider for a board review.The missing studies, with the exception of two (2), were located and resent and were confirmed accessible.The provider was informed of the status of the two studies.The customer/provider noted the missing studies within their database for future reference if needed.The cause of the reported problem could not be determined and the reason conclusion code 4315 (cause not established) was used.No further actions are anticipated at this time due to the issue being readily apparent to the user, a notation made within the customer/provider's database, and no known impact to the patient.Revised information contained in this supplemental report includes the following: a1 - patient identifier - unknown.B1 - indication of product problem.D4 - version correction.G1-2 - updated contact office - name/address.G4 - date new information received by manufacturer (case closure date 4/28/2017).G7 - indication that this is follow-up report 001.H1 - indication of malfunction as reportable event.H2 - indication of correction (software release date) and additional information.H4 - added device manufacture date (7/21/2015).H6 - evaluation codes: methods code: 4112 - analysis of data provided by user/third party.Results code: 4215 - data storage or loss of data.Conclusions code: 5315 - cause not established.H10 - indication of additional manufacturer information and corrected data are contained in this follow-up report.

• Brand Name: ICONNECT ENTERPRISE ARCHIVE
• Type of Device: EA LMB DEVICE DIGITAL IMAGE STORAGE
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 6408538
• MDR Text Key: 70099910
• Report Number: 2183926-2017-00073
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K09291524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ICONNECT ENTERPRISE ARCHIVE V10.0.2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1