BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12178906 · Received July 16, 2021

    Report

    Report Number
    9610877-2021-10137
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    May 18, 2021
    Report Date
    July 16, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    UDI-DI
    04961333225262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION SUMMARY IT WAS CAUSED DUE TO THE MALFUNCTION ON THE POWER SUPPLY UNIT. REPLACED PARTS IN THIS COMPLAINT ARE AS FOLLOW. POWER SUPPLY UNIT DUE TO MALFUNCTION. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THE LAMP DID NOT LIGHT AND ERROR CODE 03-4000 (MAIN LAMP LIGHTING FAILURE) OCCURRED. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079022 PENTAX VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000 04961333225262

    Patients

    Seq Age Sex Outcome Treatment
    1