BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222461 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10352
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    March 26, 2021
    Report Date
    July 24, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO AN OVERCURRENT FLOWING WHEN THE PROCESSOR WAS TURNED ON. MODEL EPK-I7010-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K182004. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    WHEN THE PROCESSOR POWERS ON, THE FUSE BLOWN. AFTER REPLACING NEW FUSE, THE PROCESSOR CAN WORK WELL. 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
    1119427 PENTAX VIDEO PROCESSOR PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I7000

    Patients

    Seq Age Sex Outcome Treatment
    1