MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE EYE STATION; SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC

Model Number MERGE EYE STATION V. 10.6.61

Device Problem Patient Data Problem (3197)

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

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Merge eye station is a system developed by merge which in real time, converts the existing fundus camera or slit lamp to a fully-digital system.The results are journal quality images.With solutions up to 18 megapixels, the image quality is improved without replacing the fundus camera, allowing an efficient patient diagnosis.On (b)(6) 2015, the customer reported that none of their fa images from any site were showing up on symphony web.Support was able to remote in to their server and did not see any of the fa showing up in symphony web.Support also logged into the capture station to check the winstation capture and review to see if the images would show up there, however, there were gaps in the winstation records.It was discovered that this issue occured because a user deleted information from the database.There is also the potential that the user was under the impression that only one procedure was selected while there were multiple procedures selected.The system does not have any restrictions on who can access the database and delete procedures/images.This was determined to be a potential safety issue to a patient in the event images used for a diagnosis of a patient are inadvertently deleted.Merge was able to retrieve images for deleted procedures and re-import them using import from another winstation utility in the software.Some procedures for fa were still missing and will need to be retaken.This issue occurred because a user deleted information from the database.There is also the potential that the user was under the impression that only one procedure was selected while there were multiple procedures selected.(b)(4).

• Brand Name: MERGE EYE STATION
• Type of Device: SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC
• 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: 5437547
• MDR Text Key: 38227646
• Report Number: 2183926-2015-00117
• Device Sequence Number: 1
• Product Code: NFJ
• 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
• 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: 02/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE EYE STATION V. 10.6.61
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• 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