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

Model Number MERGE EYE STATION V11.2.0.637

Device Problems Device Displays Incorrect Message (2591); Application Network Problem (2879)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2016

Event Type  malfunction  

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 received information that a customer was experiencing a database failure notification while trying to use the eye station.Support determined the issue occurred as a result of an internal network issue from the customer.On (b)(6) 2016, merge healthcare received additional information the camera was non operational for a week.On (b)(6) 2016, merge healthcare received information that patients were rescheduled as a result of the database and camera issue.No direct patient impact occurred as a result of this issue.(b)(4).

• Brand Name: MERGE EYE STATION
• Type of Device: CAMERA, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): MERGE HELALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland,, WI 53029 ; 2629123570
• MDR Report Key: 5566345
• MDR Text Key: 42273968
• Report Number: 2183926-2016-00530
• Device Sequence Number: 1
• Product Code: HKI
• 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: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MERGE EYE STATION V11.2.0.637
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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