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

Model Number MERGE EYE STATION (VERSION NOT REPORTED)

Device Problems Poor Quality Image (1408); Data Problem (3196)

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

Event Date 04/17/2014

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 can be improved without replacing your fundus camera, allowing to more efficiently diagnose a patient.The customer filed an issue for a patient where the images are loading correctly but become very dark.The poor quality of the images prevents the doctor's ability to perform progression analysis properly and ultimately the patient diagnosis.(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: 5437602
• MDR Text Key: 38218831
• Report Number: 2183926-2015-00168
• 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
• 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: No Information
• Device Model Number: MERGE EYE STATION (VERSION NOT REPORTED)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2011
• 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