BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDEX

    MDR report key: 15006088 · Received July 13, 2022

    Report

    Report Number
    3005383085-2022-00002
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 20, 2022
    Report Date
    July 11, 2022
    Manufacturer
    PALODEX GROUP OY
    Product Code
    EHD
    PMA / PMN Number
    K041050
    Removal / Correction Number
    Z-0839-2020-Z-0842-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 GXPS 500 SCANNERS. FDA IS AWARE OF THE FIELD ACTION AND IT IS COVERED IN RECALLS Z-0839-2020 - Z-0842-2020. THIS CUSTOMER HAD RECEIVED 3 NOTIFICATIONS REGARDING THE FIELD ACTION SENT TO THE DENTAL PRACTICE ON (B)(6) 2020, ON (B)(6) 2021 AND ON (B)(6) 2021 AND HAD NOT YET ORDERED A REPLACEMENT PSU. REPLACEMENT UNIT RECEIVED BY CUSTOMER. THIS CONCLUDES THE INVESTIGATION.

    Description of Event or Problem · 0

    PER (B)(6), DENTAL OFFICE STATED THEIR GXPS 500 POWER SUPPLY BURNED AND IT ALSO MELTED THE PLASTIC ON THE PORT OF THE GXPS 500 POWER UNIT. USER INDICATES NO PATIENT INVOLVEMENT, NO INJURY TO PERSONNEL OR PROPERTY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349631 GENDEX EXTRAORAL SOURCE X-RAY SYSTEM EHD PALODEX GROUP OY GXPS 500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown