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

Model Number MERGE EYE STATION V. 11.2.1

Device Problems Disconnection (1171); Connection Problem (2900); Device Operational Issue (2914)

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

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Merge eye station is an image capture software and digital interface for use in conjunction with existing opthalmic fundus cameras to take images of the eye.It performs fluorescein angiography, red free and color, icg still-image photography and video imaging.On (b)(6) 2015, the customer reported the 5000 camera is not communicating with eyestation software resulting in patients not being seen.Merge went on-site and corrected the issue with portable system; he also corrected issue with video adapter.Reference: (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: 5437865
• MDR Text Key: 38219710
• Report Number: 2183926-2015-00301
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Modification/Adjustment
• 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: MERGE EYE STATION V. 11.2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1