BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12272347 · Received August 4, 2021

    Report

    Report Number
    9610877-2021-10520
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    February 25, 2021
    Report Date
    August 4, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    UDI-DI
    04961333232918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-I5500C IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. EVALUATION SUMMARY- IT WAS CAUSED THE SOFTWARE ERROR. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. ENTRY OF PATIENT DATA NOT POSSIBLE. ERROR MESSAGE: AN ERROR OCCURRED DURING INITIALIZATION OF PATIENT DATABASE, AND ADDITIONAL SYSTEM ERROR 002-0006(PATIENT_DATABASE_ERROR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169356 PENTAX IMAGINA PROCESSOR (INCLUDES I-SCAN)-INT PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I5500C 04961333232918

    Patients

    Seq Age Sex Outcome Treatment
    1