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

Model Number 11.2.1

Device Problems Loss of Data (2903); Patient Data Problem (3197)

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

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation into the root cause of the problem is underway at the time of this report.

Event Description

On dec.3/2015, a preliminary investigation into a merge eye station problem with saving from the import station to a server found that the image import procedure had renamed the header for one patient's images with the header for a different patient's images.Further investigation revealed that this had happened to other images as well.In addition, at one point in the past the database had been rolled back and it appears that over 2000 stored images were lost.

Manufacturer Narrative

An investigation into the complaint confirmed that two different patient's eye scan images were merged into one file.The merge eye station is designed to mitigate the merging of different patient scans.Therefore, the investigation focused on what occurred at the complainant's site that resulted in the merging of two different patient scans.Merge technical support worked with the customer to determine what workflows or situations contributed to this malfunction.The customer revealed that a previously decommissioned eyecare workstation, that still had patient scans stored on it, had been brought back online.This resurrection of the decommissioned workstation caused older patient scans to be merged with new patient scans in the database.This occurred because some old and new scans had the same identifier.Merge technical support has worked with the customer and identified and quarantined all files, old and new, that were merged together.The user was immediately notified of this issue when attempting to pull up a newer patient record.Merge eye station is designed to parse a file for inconsistent patient data prior to opening the file.Any file of images that contains inconsistent patient data, produces an error message notifying the user that the file is identified for patient x, but patient y's information is present in the file.The user has to confirm that they want to proceed and view the images regardless of the error.Investigation activities did confirm a malfunction that resulted in the merging of dissimilar patient scans.However, this malfunction occurred as a result of a decommissioned eye station being brought back online with old patient data still residing on the system.A situation such as this is not likely to occur in the future.Any inconsistent patient information in an eye station file causes an error message to appear.This error is readily apparent to the user.The complainant confirmed that no patient injury or death occurred as a result of this malfunction.

Event Description

On (b)(6) 2015, a preliminary investigation into a merge eye station problem with saving from the import station to a server found that the image import procedure had renamed the header for one patient's images with the header for a different patient's images.Further investigation revealed that this had happened to other images as well.In addition, at one point in the past the database had been rolled back and it appears that over 2000 stored images were lost.

• Brand Name: MERGE EYE STATION
• Type of Device: OPHTHALMIC IMAGE MANAGEMENT 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 drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5339774
• MDR Text Key: 34922018
• Report Number: 2183926-2015-00031
• 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,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11.2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2012
• 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