BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222460 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10351
    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. THIS DEVICE IS NOT MARKETED IN US, THEREFORE 510K IS NOT APPLICABLE. 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

    THE PROCESSOR POWERED ON, THE FUSE BLOWN. AFTER REPLACING A NEW FUSE, THE PROCESSOR POWERS ON NORMALLY. 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
    1119421 PENTAX VIDEO PROCESSOR PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I7000

    Patients

    Seq Age Sex Outcome Treatment
    1