BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGORA OPTIME

    MDR report key: 13018602 · Received December 16, 2021

    Report

    Report Number
    3005383085-2021-00001
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 16, 2021
    Manufacturer
    PALODEX GROUP OY
    Product Code
    EHD
    PMA / PMN Number
    K041050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE RELATES TO THE 7-8 YEARS OLD DEFECTIVE POWER SUPPLY UNIT (PSUS) OF DIGORA OPTIME / SCAN EXAM SCANNERS. FDA IS AWARE OF THE FIELD ACTION AND IT IS COVERED IN RECALLS Z-0839-2020 - Z-0842-2020. THIS IS THE FIRST REPORT WE HAVE RECEIVED OF A USER IN THE UNITED STATES EXPERIENCING THIS MALFUNCTION. THIS CUSTOMER HAD RECEIVED 3 NOTIFICATIONS REGARDING THE FIELD ACTION SENT TO THE DENTAL PRACTICE ON 08/25/2020, 09/30/2021 AND 11/5/2021 AND HAD NOT YET ORDERED A REPLACEMENT PSU. THE DEVICE IS BEING REPLACED.

    Additional Manufacturer Narrative · 0

    THIS ISSUE RELATES TO THE 7-8 YEARS OLD DEFECTIVE POWER SUPPLY UNIT (PSUS) OF DIGORA OPTIME / SCAN EXAM SCANNERS. FDA IS AWARE OF THE FIELD ACTION AND IT IS COVERED IN RECALLS Z-0839-2020 - Z-0842-2020. THIS IS THE FIRST REPORT WE HAVE RECEIVED OF A USER IN THE UNITED STATES EXPERIENCING THIS MALFUNCTION. THIS CUSTOMER HAD RECEIVED 3 NOTIFICATIONS REGARDING THE FIELD ACTION SENT TO THE DENTAL PRACTICE ON 08/25/2020, 09/30/2021 AND 11/5/2021 AND HAD NOT YET ORDERED A REPLACEMENT PSU. THE DEVICE IS BEING REPLACED.

    Description of Event or Problem · 0

    DENTAL IMAGING PLATE SCANNER DEVICE'S POWER SUPPLY UNIT HAS HAD A SHORT CIRCUIT. DENTIST STATES THAT THERE WAS NOT A FIRE BUT MORE SO THE POWER SUPPLY SHORTING AND MELTING TO THE INSIDE OF THE UNIT. USER SAYS NO PATIENT WAS INVOLVED, NO INJURY TO PERSONNEL OR PROPERTY DAMAGE OCCURRED. DEVICE IS NOW NOT FUNCTIONAL.

    Description of Event or Problem · 0

    DENTAL IMAGING PLATE SCANNER DEVICE'S POWER SUPPLY UNIT HAS HAD A SHORT CIRCUIT. DENTIST STATES THAT THERE WAS NOT A FIRE BUT MORE SO THE POWER SUPPLY SHORTING AND MELTING TO THE INSIDE OF THE UNIT. USER SAYS NO PATIENT WAS INVOLVED, NO INJURY TO PERSONNEL OR PROPERTY DAMAGE OCCURRED. DEVICE IS NOW NOT FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917037 DIGORA OPTIME EXTRAORAL SOURCE X-RAY SYSTEM EHD PALODEX GROUP OY DXR-50

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown