BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 16189523 · Received January 17, 2023

    Report

    Report Number
    3002808148-2023-00502
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    December 19, 2022
    Report Date
    February 23, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    HIF
    UDI-DI
    04953170324147
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PLEASE SEE THE UPDATES IN SECTIONS H6 AND H10. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 6 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE DEVICE DID NOT TURN ON AND AN ALARM WAS GENERATED DUE TO A DEFECTIVE CIRCUIT BOARD AND THE INSUFFICIENT AIR SUPPLY WAS LIKELY DUE TO THE FAILURE OF THE PRIMARY PRESSURE REDUCER. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE REFERENCED DEVICE WAS RETURNED TO THE OLYMPUS SERVICE CENTER. THE SERVICE INSPECTION CONFIRMED THE CUSTOMER¿S REPORTED ISSUE, THE SCREEN BLACKS OUT WITH ALARM DUE TO A DEFECTIVE CIRCUIT (CR) BOARD. ALSO, THE AIR SUPPLY IS INSUFFICIENT DUE TO A DEFECTIVE PRIMARY REGULATOR UNIT. THE DEVICE HAS NOT BEEN REPAIRED IN THE LAST YEAR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE END-USER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE.

    Description of Event or Problem · 0

    OLYMPUS (OSH) WAS INFORMED VIA REPAIR REQUEST THE HIGH FLOW INSUFFLATION UNIT CANNOT BE TURNED ON. THE CUSTOMER REPORTED PROBLEM WAS FOUND AT REPROCESSING. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7422 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF SHIRAKAWA OLYMPUS CO., LTD. UHI-4 04953170324147

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS MODEL CV-190.