BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVECTA S-PAN

    MDR report key: 4412400 · Received January 9, 2015

    Report

    Report Number
    2428225-2014-00004
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Date of Event
    December 9, 2014
    Report Date
    January 9, 2015
    Manufacturer
    VATECH CO, LTD
    Product Code
    MUH
    PMA / PMN Number
    K130585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO OPERATOR OR PT INJURY ASSOCIATED WITH THIS INCIDENT, BUT AN OBSERVATION DESCRIBED BY A CUSTOMER/DENTIST DURING ROUTINE USE OF X-RAY IMAGES. IMAGES CANNOT BE LOST BECAUSE IMAGES ARE BACK-UP BY THE TWAIN INTERFACE. IMAGES CAN BE EASILY RETRIEVED AND ASSIGNED TO THE PROPER PT BY DENTIST BASED ON THEIR CLINICAL EXPERIENCE AND SPECIFIC KNOWLEDGE OF THE PT'S DENTAL ANATOMY.

    Description of Event or Problem · 1

    OBSERVED THE POTENTIAL OF THE UTILITY SOFTWARE DRIVER TO PRESENT X-RAY AND PLACE X-RAY IMAGES IN A PC FOLDER THAT COULD THEN BE CAPTURED BY THE DENTIST AND MATCHED TO A NEW OR WRONG PT. DENTIST WOULD DETECT AND MATCH THE PROPER IMAGE TO A PT BASED THEIR CLINICAL EXAMINATION AND COMPLETE CLINICAL ASSESSMENT BEFORE USING PANORAMIC X-RAY IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20273 PROVECTA S-PAN DIGITAL X-RAY IMAGING SYTEM MUH VATECH CO, LTD A7350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1