MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE EYE STATION; CAMERA, OPHTHALMIC, AC-POWERED

Model Number MERGE EYE STATION V11.3.2

Device Problem Optical Distortion (3000)

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

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

Customer was provided a replacement camera.Initial investigation information indicates a bad sensor was the likely cause of the pixilated images.

Event Description

Merge eye station is intended to be used in conjunction with existing ophthalmic fundus cameras to take images of the eye, perform fluorescein angiography, red free, color and icg still-image photography as well as video imaging.On (b)(6) 2016, merge healthcare was notified that images on the camera were coming in extremely pixilated and staticky, making the images difficult to read.This resulted in a delay in care as patients had to be rescheduled until a new camera could be received.There is no known impact to patients as a result of this issue.(b)(4).

Manufacturer Narrative

The following information was sent in the follow-up report.Additional 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.The camera was returned on 09/19/2016.The product was evaluated and it was determined there was hardware failure and the sensor was bad.The sensor was replaced and the product was returned to service stock.Method code: 10: actual device evaluated.Results code: 140: wear problem.Corrected data: address and name added.Conclusion code changed from 63: repair and return to 51:maintenance deficiency.If remedial action taken: replace.

• Brand Name: MERGE EYE STATION
• Type of Device: CAMERA, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland, WI 53029
• MDR Report Key: 5639497
• MDR Text Key: 44687300
• Report Number: 2183926-2016-00573
• Device Sequence Number: 1
• Product Code: HKI
• Combination Product (y/n): N
• PMA/PMN Number: K913929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE EYE STATION V11.3.2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1