BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 21349426 · Received February 10, 2025

    Report

    Report Number
    3002808148-2025-02005
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    December 6, 2024
    Report Date
    July 22, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    HIF
    PMA / PMN Number
    K122180
    Removal / Correction Number
    FY24-OMSC-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS TO INFORM CORRECTION TO SECTION H9 OF THE INITIAL MDR REPORTED UNDER 3002808148-2025-02005-00. CORRECTION- H9 SHOULD BE BLANK AS THIS REPORTABLE MALFUNCTION IS UNRELATED TO FY24-OMSC-06.

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: IT IS PRESUMED THAT THE LED LIGHTING IS POOR DUE TO A FAILURE OF THE FRONT PANEL UNIT. A ROOT CAUSE COULD NOT BE IDENTIFIED. REVIEW OF DEVICE SERVICE HISTORY RECORD FOR THE PAST 12 MONTHS FOUND NO ISSUES OR ABNORMALITIES THAT ARE RELATED TO THE REPORTED PHENOMENON. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE INSUFFLATION UNIT EXHIBITED THE FRONT PANEL LIGHTS FLICKERING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960187 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF SHIRAKAWA OLYMPUS CO., LTD. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown