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

Model Number MERGE EYE STATION

Device Problem Computer Operating System Problem (2898)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2016

Event Type  malfunction  

Event Description

Merge winstation 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 customer reported experiencing issues with the eye station not working.On (b)(4) 2016, follow-up with the account revealed the issue led to a delay in patient care because images could not be captured for several days.No patient harm occurred.The issue was resolved by replacing the hardware.Per (b)(6), no patient harm occurred as a result of the delay in treatment or diagnosis.All patients were rescheduled and none of the events led to an emergency situation.

• Brand Name: MERGE WINSTATION
• Type of Device: CAMERA, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr.; harland, WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut drive; hartland, WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5482177
• MDR Text Key: 40169499
• Report Number: 2183296-2016-00461
• 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: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE EYE STATION
• Device Catalogue Number: 11.2.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1