MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE EYESTATION; CAMERA, OPHTHALMIC, AC-POWERED

Model Number MERGE EYE STATION V11.2.1

Device Problems Communication or Transmission Problem (2896); Loss of Data (2903)

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

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is further investigating this customer's allegation.Additionally, a backup of the capture workstation was created to ensure that a second source of data is available.When additional information becomes available a supplemental report will be submitted.

Event Description

Merge eye station is intended to be used in conjunction with existing ophthalmic fundus cameras to take images of the eye, perform fluorescein angiography, red free, color and icg still-image photography as well as video imaging.On (b)(6) 2016, merge healthcare was notified that images were not transferred to the server after an autodownload.Then on (b)(6) 2016, additional information was received from the customer indicating that there have been a few incidences where photos taken on the capture station disappeared from the system.The customer did not believe that the missing images were due to deletions by users.An allegation of missing images may result in a delay of patient diagnosis or treatment.However, there is no known patient impact that occurred as a result of the missing images.(b)(4).

Manufacturer Narrative

Additional narrative: this supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 07/15/2016.During troubleshooting efforts between the customer and merge technical support, it could not be determined why the images were missing.According to the account, the images were not deleted.It is a possibility that a network issue could have caused the images to not autodownload.The product was found to be functioning correctly by support.No further issues have been reported by the account.Support created a backup on the eye station so if this happens again , the images could be found on the computer and restored.Corrected data: device code changed from 2896 to 2903 and 748- loss of data and camera.Result code 213 added -no failure detected.Conclusion code 67 added - no problem identified.Updated name and email address of mfr site - report source.

• Brand Name: MERGE EYESTATION
• Type of Device: CAMERA, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, WI 53025
• MDR Report Key: 5797398
• MDR Text Key: 49631865
• Report Number: 2183926-2016-00649
• Device Sequence Number: 1
• Product Code: HKI
• Combination Product (y/n): N
• PMA/PMN Number: K913929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE EYE STATION V11.2.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1