BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11103052 · Received December 31, 2020

    Report

    Report Number
    9610877-2020-00152
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    July 25, 2020
    Report Date
    July 25, 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. (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 AFTER STARTUP, A STRANGE NOISE WAS HEARD, A SPARK WAS WITNESSED, AND THE LAMP DID NOT TURN ON. (CHECK LOG 03-4000 AND 03-1000) NO DAMAGE DUE TO ABNORMAL NOISE AND SPARKS." 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 DEVICE WAS REPLACED WITH A SUBSTITUTE AND CONFIRMED "AUX LAMP ON.CHECK MAIN LAMP". SOFTWARE VERSION: (B)(4) SYSTEM LIFE: 3256 HOURS 17 MINUTES 26 SECONDS TOTAL LIGHTING TIME: 23 HOURS 9 MINUTES 55 SECONDS NUMBER OF LIGHTING: 1340 TIMES NUMBER OF INITIALIZATION EXECUTIONS: 4 TIMES MEASURES AGAINST DUST ON LAMP POWER BOARD: NOT SUPPORTED. DOOR CHANGE: ALREADY SUPPORTED THE IGNITER WAS FOUND TO BE THE CAUSE BECAUSE THE PHENOMENON WAS IMPROVED BY REPLACING THE IGNITER INSTALLED IN THE LAMP POWER SUPPLY. FROM THE MANUFACTURER'S ANALYSIS, IT IS CONSIDERED THAT THE CAUSE OF THE ESTIMATION IS THAT THE IGNITION VOLTAGE DROPPED DUE TO THE PROXIMITY OF THE PARTS INSIDE THE IGNITER. THE REPAIRED PRODUCT WAS RETURNED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566340 PENTAX VIDEO PROCESSOR PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000 04961333240197

    Patients

    Seq Age Sex Outcome Treatment
    1