MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE EYE STATION; SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC

Model Number MERGE EYESTATION (VERSION 5.0)

Device Problem Data Problem (3196)

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

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Merge eye station converts an existing fundus camera or slit lamp to a fully-digital system that produces journal quality images.With solutions up to 18 megapixels the image quality quality can be improved without replacing your fundus camera, allowing to more efficiently diagnose a patient.A patient was prepped for a procedure with dilated eyes and the customer was unable to obtain a capture, where the system stopped allowing the downloading or acquisition of images.This occurred after entering patient information into the eyestation application, when it froze when trying to start a capture session.There were no errors in application log.The manufacturer could not see any errors in the system event viewer.The digital camera was being seen by the os properly.The capture station was rebooted.It was determined to be an sql database related issue.It appears that sql threads are being deadlocked/blocked for extended periods of time, causing all capturing to be blocked.It was determined that using the oldest eyestation version with the newest eye care pacs was causing the issue.The site was advised to use the same version release level, for example (ecp-5.1 and eyestation 11.5.1) or (ecp-5.0 and eyestation 11.5.0) as temporary solution.The manufacturer has also proposed to split drs and non-drs databases.(b)(4).

• Brand Name: MERGE EYE STATION
• Type of Device: SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC
• 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 dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437592
• MDR Text Key: 38228058
• Report Number: 2183926-2015-00149
• Device Sequence Number: 1
• Product Code: NFJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913929
• 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: 02/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MERGE EYESTATION (VERSION 5.0)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-02/15/2016-044-C
• Patient Sequence Number: 1