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

Model Number MERGE EYE STATION V11.2.1

Device Problems Problem with Software Installation (3013); Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare's support determined the system was configured to a sync box that was no longer working and deleted the configuration within the computer for complete resolution.

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 a camera was disconnecting during a capture session.Support supplied a replacement firewire card and a loaner camera but the issues still occurred.Additional information received from support indicated some images were able to be captured; however, the images were showing up with the incorrect patient information.The customer indicated that there was no direct patient harm that occurred as a result of the delay in treatment or as a result of the mixing of patient information.(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 dr.; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5540662
• MDR Text Key: 41619075
• Report Number: 2183926-2016-00510
• 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: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE EYE STATION V11.2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2016
• 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