BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 11499872 · Received March 16, 2021

    Report

    Report Number
    8010047-2021-03812
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Report Date
    May 13, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE DEVICE WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. BASED ON THE INSPECTION RESULTS BY OLYMPUS KOREA CO., LTD. (OKR), OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) ASSUMED THAT THE REPORTED EVENT WAS CAUSED BY MALFUNCTION OF THE PRESSURE SENSOR MOUNTED ON THE MAIN BOARD. THIS MALFUNCTION MAY HAVE BEEN CAUSED BY INTRUSION OF LIQUID FOREIGN MATTER DUE TO FOLLOWINGS; -BACKFLOW FROM THE WATER OUTLET -FOREIGN MATTER CONTAINED IN CARBON DIOXIDE -LIQUID SPILLED ON THE DEVICE IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND FOLLOWINGS; THE FRONT PANEL DID NOT WORK WITH A BEEPING SOUND WHEN THE POWER WAS TURNED ON. THIS EVENT WAS CAUSED BY THE SENSOR ON THE PRINTED CIRCUIT BOARD NOT WORKING PROPERLY. LIQUID FOREIGN MATTER MAY HAVE ENTERED THE SENSOR INSIDE THE PIPE. THE EXACT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN IDENTIFIED BY LEGAL MANUFACTURER OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THIS DEVICE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE OPERATION OF THE DEVICE WAS POOR DURING PREPARATION FOR USE. REPORTEDLY, THERE WAS A PROBLEM WITH THE POWER SUPPLY OR FRONT PANEL OF THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394989 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1