BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12531115 · Received September 26, 2021

    Report

    Report Number
    9610877-2021-00918
    Event Type
    Malfunction
    Date Received
    September 26, 2021
    Date of Event
    August 30, 2021
    Report Date
    March 14, 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: THE CAUSE WAS THE DISAPPEARANCE OF THE RESISTANCE PATTERN OF THE CHIP RESISTANCE DUE TO THE ELECTROCHEMICAL CORROSION PHENOMENON. CORRECTION INFORMATION: G6: FOLLOW UP #1 H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT ADDITIONAL INFORMATION: H4: DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. 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.

    Description of Event or Problem · 0

    WHEN THE POWER WAS TURNED ON (B)(6) 2021, THE ERROR CODE 03-0200 WAS DISPLAYED AND THE S TERMINAL WAS NO LONGER OUTPUT. THERE IS LOG HISTORY. SINCE IT OCCURRED BEFORE USE, THERE IS NO HEALTH HAZARD TO PATIENTS AND MEDICAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428634 PENTAX VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown