BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALM SCAN VF2000 G2

    MDR report key: 13584171 · Received February 22, 2022

    Report

    Report Number
    MW5107614
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    February 17, 2022
    Report Date
    February 17, 2022
    Manufacturer
    MICRO MEDICAL DEVICES, INC.
    Product Code
    HPT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNRELIABLE RESULTS FROM VISUAL FIELD TESTING DEVICE, COULD POTENTIALLY CAUSE MISDIAGNOSE GLAUCOMA, WHICH IS A VISION THREATENING PROBLEM, THE DEVICE WAS TESTED FOR FULL THRESHOLD, BUT THEY ARE ADVERTISING AND USING A METHOD THEY CALLED FAST INTERACTIVE THRESHOLD, WHICH STOP TESTING ANY GIVEN POINT WHEN THE PATIENT SEE THE AVERAGE, THIS WOULD POTENTIALLY MISS ANY PROBLEM IN INDIVIDUALS PERFORM BETTER THAN AVERAGE, I REPORTED THE PROBLEM TO THE MANUFACTURER, THEY TRIED TO FIX IT VIA UPDATE, WHEN FAILED THEY ARE TRYING TO CONVINCE ME THAT THE DEVICE IS FINE AND THIS METHOD IS RELIABLE, THEY DON'T HAVE ANY STUDIES TO CONFIRM THEIR CLAIM. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER FOR REPORT MW5107614 ON 03/03/2021 TO UNCHECK CONFIDENTIAL BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672901 PALM SCAN VF2000 G2 PERIMETER, AUTOMATIC, AC-POWERED HPT MICRO MEDICAL DEVICES, INC. VF2000 G2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability