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

Model Number MERGE EYE STATION 11.2

Device Problem Application Network Problem (2879)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

Based on the provided information within this complaint, the issue occurred because of a power outage on the account's end; however, because the local image was not set up from merge healthcare on the account's system, downtime occurred with the system and a delay in patient care was experienced.Merge healthcare technical support was able to resolve the issue by pointing to the local mssql db and configuring the camera settings for the stand alone capture.According to information received from the customer, the fix implemented by support fully corrected the issue.

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) 2018, merge healthcare received information from an account that the stand alone feature of the camera did not work during a power outage.This resulted in a delay in diagnosis and treatment as patients had to be rescheduled.All of the rescheduling occurred within one week.It was further reported that no patient harm occurred as a result of the delay.Support determined there was an issue with the odbc connector setting pointing to the local mssql db and corrected it.The camera settings for the stand alone capture were also configured.The customer reported the issue has been resolved.(b)(4).

• Brand Name: MERGE EYE STATION
• Type of Device: CAMERA, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland, WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, WI 53029
• Manufacturer Contact: meg mucha ; 900 walnut ridge; hartland,, WI 53029 ; 2629123514
• MDR Report Key: 7482144
• MDR Text Key: 107331186
• Report Number: 2183926-2018-00028
• Device Sequence Number: 1
• Product Code: HKI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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