BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETCAM 3

    MDR report key: 4217814 · Received August 13, 2014

    Report

    Report Number
    2952489-2014-00003
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Report Date
    August 5, 2014
    Manufacturer
    CLARITY MEDICAL SYSTEMS INC.
    Product Code
    HKI
    PMA / PMN Number
    K090326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483473 RETCAM 3 OPHTHALMIC CAMERA HKI CLARITY MEDICAL SYSTEMS INC. RETCAM 3

    Patients

    Seq Age Sex Outcome Treatment
    1