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

Model Number MERGE EYE STATION 11.5

Device Problem Computer Operating System Problem (2898)

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

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Based on follow-up information from the customer, the replacement of the motherboard on the desktop computer resolved the issue.The customer's merge eye station account has been active since 2006 and there are no previous service records indicating that a workstation motherboard was serviced.No further investigation or action required.

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) 2018, merge healthcare was notified that a merge eye station was unable to boot at start-up.Support determined the hard drives would need to be replaced and on (b)(6) 2018, the hard drives were shipped.Dell support also performed an investigation and determined the issue was related to the motherboard of the pc.On 06/25/2018, additional information was received from the account.According to the new information, the issue impacted patient care, as patients had to be rescheduled two(2) weeks out.This issue is being reported due to the potential for harm related to the inability of the eye care professional to obtain the necessary information for procedures.No patient harm was reported as a result of this issue.Reference complaint number: (b)(4).

• Brand Name: MERGE EYE STATION
• Type of Device: CAMERA, OPHTHALMIC, AC-POWERED
• 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: meg mucha ; 900 walnut ridge drive; hartland,, WI 53029 ; 2629123514
• MDR Report Key: 7643081
• MDR Text Key: 112736788
• Report Number: 2183926-2018-00053
• Device Sequence Number: 1
• Product Code: HKI
• 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
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE EYE STATION 11.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• 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