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

Model Number MERGE EYE STATION 10.6.61

Device Problems Device Issue (2379); Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

Initial information reported by customer indicates that the computer at the customer site was operating on xp and was greater than 5 years old.

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) 206, merge healthcare received information indicating a computer had failed and unarchived data was lost.Because a hard drive failure and lost images can result in a delay of care, there is a potential risk of harm to a patient.There is no known direct patient impact as a result of this issue.Reference complaint number (b)(4).

Manufacturer Narrative

Additional information, received from the account on 05/12/2016, indicates the issue was resolved when the data was moved to another system.No patient harm occurred as a result of the delay in care that was experienced.

• 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 ride drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5572081
• MDR Text Key: 42502451
• Report Number: 2183926-2016-00542
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE EYE STATION 10.6.61
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1