BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12866390 · Received November 23, 2021

    Report

    Report Number
    9610877-2021-01644
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    November 19, 2021
    Report Date
    May 11, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: WE CHECKED THE RETURNED UNIT AND CONFIRMED, THAT THE PROCESS BOARD FAILURE. BASED ON THE RESULT, WE CONCLUDED, THAT IT WAS CAUSED, DUE TO THE PROCESS BOARD FAILURE. RESULTED IN COMMUNICATION ERROR. CORRECTION INFORMATION: H6: CODING CHANGED, BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-3000-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K172156. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    AFTER STARTING THE PROCESSOR, ERROR CODE 03-0026 OCCURS. REBOOTING ACCORDING TO THE DISPLAY DOES NOT IMPROVE. THERE IS A CONNECTION FAILURE, AND USB CAPTURE, INSPECTION HISTORY OUTPUT, AND SETTING COPY CANNOT BE PERFORMED. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763544 PENTAX VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown