BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 7124811 · Received December 18, 2017

    Report

    Report Number
    8010047-2017-02004
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 28, 2017
    Report Date
    March 11, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    PK110294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 1

    THE REFERENCED UHI-4 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, THEREFORE OMSC CANNOT EVALUATE THE UHI-4. THE EXACT CAUSE OF THIS PHENOMENON CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS THE POSSIBILITY OF THIS PHENOMENON IS ATTRIBUTED TO THE HANDOVER OF THE WRONG GAS BOTTLE TO OLYMPUS SALES REPRESENTATIVE BY THE FACILITY NURSE WITHOUT ADEQUATE CONFIRMATION. OMSC STATED THAT ONLY CO2 WAS ALLOWED IN THE INSTRUCTION MANUAL OF UHI-4. OMSC CHECKED THE MANUFACTURE HISTORY OF THE UHI-4, THERE WAS NO IRREGULARITY FOUND. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THE FOLLOWING. WHEN THE FUNDOPLICATION PROCEDURE WAS PERFORMED, THE FACILITY NURSE GAVE OLYMPUS SALES REPRESENTATIVE THE GAS BOTTLE. THE SALES REPRESENTATIVE CONNECTED THE BOTTLE TO THE UHI-4. AFTER THE APPROXIMATELY TEN MINUTES, THE SALES REPRESENTATIVE FOUND THAT THE WRONG BOTTLE (ARGON GAS BOTTLE) WAS CONNECTED TO THE UHI-4 AND HE REPORTED TO THE NURSE THAT ARGON GAS WAS INSUFFLATED TO THE PATIENT. THE ARGON GAS BOTTLE WAS EXCHANGED TO CO2 GAS BOTTLE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905802 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1