BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11103289 · Received December 31, 2020

    Report

    Report Number
    9610877-2020-00153
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    July 11, 2020
    Report Date
    July 13, 2020
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    UDI-DI
    04961333240197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPORT FOR EXPORT. INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING. (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2020 STATING "ON (B)(6) 2020, WHEN THE LAMP WAS TURNED ON BEFORE USE, A STRANGE NOISE WAS HEARD, A SPARK WAS WITNESSED, AND THE LAMP DID NOT TURN ON. (ERROR CODE: 03-4000) NO DAMAGE DUE TO ABNORMAL NOISE AND SPARKS. WE REPLACED IT WITH A SUBSTITUTE ON (B)(6) 2020 AND CONFIRMED THE REPRODUCTION IN MITAKA.." INVOLVING PENTAX MEDICAL VIDEO PROCESSOR, MODEL EPK-3000, SERIAL NUMBER (B)(4). NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER WAS REPORTED. DURING PENTAX MEDICAL INSPECTION, THE FAILURE WAS CONFIRMED. SOFTWARE VERSION: (B)(4). SYSTEM LIFE: 487 HOURS 3 MINUTES 5 SECONDS. TOTAL LIGHTING TIME: 212 HOURS 5400 SECONDS. NUMBER OF LIGHTING: 1331 TIMES. NUMBER OF INITIALIZATION EXECUTIONS: 0 MEASURES AGAINST DUST ON LAMP POWER BOARD: NOT SUPPORTED. DOOR CHANGE: ALREADY SUPPORTED. THERE WAS A LAMP POWER FAILURE DUE TO DUST. THE REPAIRED PRODUCT WAS RETURNED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564108 PENTAX VIDEO PROCESSOR PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000 04961333240197

    Patients

    Seq Age Sex Outcome Treatment
    1