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

Model Number V. 11.3.2

Device Problem Patient Data Problem (3197)

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

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

Upon restrospective 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.Customer reported there was an issue with his patients' images not coming up properly when imported through the dicom.It was discovered that the customer system was set up to validate with patient mrn only.When importing through the esiu it was pulling in other patient data because it was validating against name, mrn, and birthdate.It was found that multiple patients were possibly not being imported properly.In this specific case, the mrn did not match an already existing patient and therefore, the data was imported under "unknown".This was determined to be a potential safety issue should the images not be imported properly, causing a misdiagnosis.On (b)(6) 2015, the customer explained they only want to validate on mrn because they have devices where the techs only input the mrns.He would like to use esiu and to continue validating on mrn only.Reference: (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: 5437921
• MDR Text Key: 38225328
• Report Number: 2183926-2015-00317
• 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
• Remedial Action: Recall
• 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: Health Professional
• Device Model Number: V. 11.3.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-02/15/2016-039-C
• Patient Sequence Number: 1