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

Model Number MERGE EYE STATION

Device Problems Data Problem (3196); Patient Data Problem (3197)

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

Event Date 07/20/2015

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 opthalic fundus cameras to take images of the eye.It performs fluorescein angiography, ref free and color, icg still-image photography and video imaging.On 7/20/15, merge was contacted to report that images were imported under "unknown".Merge took out l for comparepatient_db in esiu on all import stations.The customer was shown how to complete this and the system was restarted.The systems are design to allow sites to validate patient information at the time of import on one patient's demographics.Additionally, certain releases will overwrite the patient name if the medical record numbers (mrns) match but the names do not or will import the patient data as "unknown".Validation on one patient's demographics could potentially introduce patient data mixup or delay in patient care.(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: 5437932
• MDR Text Key: 38227887
• Report Number: 2183926-2015-00319
• 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: MERGE EYE STATION
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2015
• 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
• Removal/Correction Number: 2183926-02/15/2016-039-C
• Patient Sequence Number: 1