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

Model Number MERGE EYE STATION V11.2.1

Device Problems Fumes or Vapors (2529); Loss of Data (2903); Operating System Becomes Nonfunctional (2996); Noise, Audible (3273)

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

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

Aged electrolytic capacitors rupturing on pc motherboards are common hardware failures for pcs that are older than 5 years.No reports of any harm to patients or users.Replacement of the failed hardware was successful.

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 an eye station would not boot up.Follow-up with the account occurred on 05/03/2016.According to the customer, the system crashed, there was a loud popping sound, and an electrical smell was omitted.The customer reported the motherboard "blew up" during the imaging process.All of the images for the patient were lost and had to be retaken.No direct patient harm occurred.The eye station was returned.No signs of a fire were observed.The motherboard was replaced and the eye station was returned to the customer.(b)(4).

• Brand Name: MERGE EYE STATION
• Type of Device: CAMERA, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland, WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland, WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge dr.; hartland,, WI 53029 ; 2629123570
• MDR Report Key: 5668900
• MDR Text Key: 45575570
• Report Number: 2183926-2016-00585
• Device Sequence Number: 1
• Product Code: HKI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K91329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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