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

Model Number	MERGE EYE STATION V. 11.6.1
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has requested a site visit.A site visit has been scheduled by the support team.A follow-up report will be provided once the site visit has occurred.
Event or Problem 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 11/14/2018, merge healthcare received information from an account that a system is freezing up during fa imaging.(fluorescein angiogram).The customer has to exit out of the software, re-open it, and re-load the patient's record once the fluorescein dye has been injected into the patient, affecting the arterial venous flush times.Additionally, the images are very blurry and necessary details for diagnosis and treatment are difficult to see.Support has scheduled a site visit in order to trouble shoot and correct the issue.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.Reference complaint (b)(4).

• Brand Name: MERGE EYE STATION
• Common Device Name: CAMERA, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, WI 53029
• MDR Report Key: 8149883
• Report Number: 2183926-2018-00099
• Device Sequence Number: 295276
• Product Code: HKI
• UDI-Device Identifier: 00842000100140
• UDI-Public: 00842000100140
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K913929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: MERGE EYE STATION V. 11.6.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1