MAUDE Adverse Event Report: MERGE HEALTHCARE EYE STATION IMPORT UTILITIES; MEDICAL DEVICE DATA SYSTEM

Model Number ESIU 1.1.3

Device Problems Disconnection (1171); Connection Problem (2900); Device Operational Issue (2914)

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

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Merge eye station is an image capture software and digital interface for use in conjunction with existing ophthalmic fundus cameras to take images of the eye.It performs fluorescein angiography, red free and color, icg still-image photography and video imaging.It was reported by a customer on (b)(6) 2015 that an eye station digital camera would not connect.This caused the patient to be re-injected with dye after the issue was resolved by unplugging and replugging in the firewire cable.Anytime anything enters the body, there are always risks associated; however the water-based dye does not pose any additional harm to the body.If a patient is allergic to the dye, the patient might experience nausea, vomiting, or hives regardless of dose provided.Also, in some cases the patient might require an additional dose to ensure visibility in the eye.If the photographer does not see results within 8-15 seconds estimated circulation time from arm to eye (based on age, health conditions, etc.) the photographer can re-inject the patient.Finally the photographers are instructed to set up the capture systems prior to injecting the patients, ensuring systems are ready for image capture.(b)(4).

• Brand Name: EYE STATION IMPORT UTILITIES
• Type of Device: MEDICAL DEVICE DATA SYSTEM
• 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 dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437868
• MDR Text Key: 38227958
• Report Number: 2183926-2015-00134
• Device Sequence Number: 1
• Product Code: OUG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ESIU 1.1.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2015
• 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