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

Model Number MERGE EYE STATION 11.2.1

Device Problems Computer Operating System Problem (2898); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare technical support evaluated and investigated the customer's eye station.Support attempted to determine what the cause of the database error and the under developed images.The cause was not determined and technical support was unable to replicate the customer's allegation.The customer has not experienced this same malfunction since (b)(4) 2017.

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)(4) 2017, merge healthcare received information that an error message regarding a failed to lock database error occurred and images that were captured came in as under developed.The support group was unable to rebuild the images and the patient was brought back in for re injection and re testing.This issue is being reported due to the potential for harm related to the inability of the eye care professional to obtain the necessary information for procedures.No patient harm occurred as a result of this issue.(b)(4).

Manufacturer Narrative

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 02/12/2018.During troubleshooting efforts between the customer and merge technical support, it was found the customer had a bad ethernet cable that was causing a network drop and disconnect on the database.The cable was replaced and the issue was resolved.It was determined the issue was not related to the merge product.Corrected data: changed from 75 no failure detected, device of specification to 71 no failure detected, device operated within specification.

• Brand Name: MERGE EYE STATION
• Type of Device: CAMERA, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): MERGE EYE STATION; 900 walnut ridge drive; harltand, WI 53029
• MDR Report Key: 7206023
• MDR Text Key: 98175426
• Report Number: 2183926-2018-00007
• 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
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE EYE STATION 11.2.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1