MAUDE Adverse Event Report: CLARITY MEDICAL SYSTEMS, INC. RETCAM 3; OPHTHALMIC CAMERA

Model Number RETCAM 3

Device Problems Computer Software Problem (1112); Application Program Problem (2880); Programming Issue (3014)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Event Description

We have met several times about this problem on version 6.3.When we finished exam and then click "exit exam and go to image review" want to exit exam and go to this patient exam review screen.But the system always go to another patient exam review screen.(serial no.(b)(4)).

Manufacturer Narrative

During imaging with a retcam 3 in (b)(6), a software anomaly was observed.Under certain user workflows, exam information on the retcam exam review screen was displayed for a patient other than the expected patient.The exam information was correct for the displayed patient.No patient injury was reported.However, there is a remote possibility if this occurs again, the user will not recognize the fact that the displayed patient is not the expected patient which could lead to delayed diagnosis or delayed treatment.The retcam 3 device serial number is (b)(4).The user has been informed to use workflows that will avoid this situation.

• Brand Name: RETCAM 3
• Type of Device: OPHTHALMIC CAMERA
• Manufacturer (Section D): CLARITY MEDICAL SYSTEMS, INC.; pleasanton CA 94588
• Manufacturer Contact: greg meyer ; 5775 west las positas blvd.; pleasanton, CA 94588 ; 8002516005
• MDR Report Key: 4217827
• MDR Text Key: 5000364
• Report Number: 2952489-2014-00002
• Device Sequence Number: 1
• Product Code: HKI
• Combination Product (y/n): N
• PMA/PMN Number: K090326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RETCAM 3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1