BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CV-5000

    MDR report key: 14052734 · Received April 8, 2022

    Report

    Report Number
    9614661-2022-00001
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 3, 2022
    Report Date
    April 8, 2022
    Manufacturer
    TOPCON CORPORATION
    Product Code
    HKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    A TECHNICIAN NOTICED THAT A VISUAL ACUITY CHART WAS BLANK AND THE POWER SUPPLY WAS SHOWING A RED LIGHT. WITHOUT TURNING OFF THE POWER SUPPLY THE TECHNICIAN REACHED BEHIND THE POWER SUPPLY TO FEEL FOR LOOSE CABLE CONNECTIONS. WHILE FEELING FOR CABLE CONNECTIONS, THE TECHNICIAN DESCRIBED THE END OF ONE OF THE CABLES SHOCKING HER. THE TECHNICIAN REPORTED THAT SHE WASN'T FEELING WELL AND HAD A HEART RATE OVER 100, SO SHE WENT TO AN URGENT CARE CLINIC A FEW HOURS AFTER THE INCIDENT. THE STAFF AT THE CLINIC ADVISED HER TO GO TO THE EMERGENCY ROOM WHERE SHE REMAINED FOR A FEW HOURS. THE TECHNICIAN INFORMED TOPCON MEDICAL SYSTEMS, INC. THAT THE EMERGENCY ROOM WARNED THAT SHE MAY FEEL JITTERY FOR UP TO A FEW WEEKS. THE TECHNICIAN WAS NOT ADMITTED TO THE HOSPITAL. THE TECHNICIAN ALSO EXPLAINED ON (B)(6) 2022 (7 DAYS POST-INCIDENT) THAT THE LEFT SIDE OF HER BODY FELT SENSITIVE. IT SHOULD BE NOTED THAT A SUSPECTED CAUSE OF THE INCIDENT INVOLVES THE USER'S ENVIRONMENT. THE IFU WARNS THAT A POWER STRIP SHOULD NOT BE USED IN THE PATIENT'S ENVIRONMENT, BUT IT WAS OBSERVED THAT THE UNIT WAS PLUGGED INTO A POWER STRIP. THE MEDICAL DEVICE INVOLVED IN THE INCIDENT WAS REPLACED ON 17-MAR-2022.THE DEVICE THAT CAUSED THIS INCIDENT IS BEING ARRANGED FOR RETURN AT THE HEAD OFFICE FOR INVESTIGATION.

    Description of Event or Problem · 0

    UPON EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT ONE OF THE CONNECTION CABLES WAS DAMAGED NEAR THE SITE OF THE SHOCK AND THIS CONNECTION CABLE WAS IDENTIFIED AS A NON-TOPCON CABLE DIFFERENT FROM WHAT IS SUPPLIED WITH THE UNIT. ADDITIONALLY, MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO FOLLOW-UP WITH THE HEALTH STATUS OF THE TECHNICIAN SHOCKED IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705022 CV-5000 REFRACTOR, MANUAL, NON-POWERED, INCLUDING PHOROPTER HKN TOPCON CORPORATION 4322149503

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female