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

Model Number MERGE EYE STATION V11.5

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare support determined that a windows upgrade had failed.Once the windows upgrade was completed, the customer's issue was resolved.

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 from an account that an eye station would not boot.On 12/20/2016, information was received from the customer that indicated patients had to be re-routed to another office for testing.In some cases, testing had to be delayed, resulting in a possible delay of diagnosis or treatment.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.(b)(4).

• Brand Name: MERGE EYE STATION
• Type of Device: CAMERA, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; 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: 6252765
• MDR Text Key: 64920267
• Report Number: 2183926-2017-00013
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE EYE STATION V11.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2014
• 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