BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 11691402 · Received April 19, 2021

    Report

    Report Number
    8010047-2021-05117
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 20, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) COULD NOT INVESTIGATE THE SUBJECT DEVICE, BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE OLYMPUS LOCAL SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON COULD NOT BE DUPLICATED. THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE OMSC COULD NOT CONFIRM THE PHENOMENON. OMSC SURMISED THAT THE REPORTED PHENOMENON WAS OCCURRED THE FOLLOWING CAUSE. IT WAS CAUSED BY A TEMPORARY MALFUNCTION OF THE EQUIPMENT. IT WAS CAUSED BY EFFECTS OTHER THAN THE DEVICE (FACILITY, POWER SUPPLY, ETC.).

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) WAS INFORMED FROM THE USER THAT DURING A PROCEDURE WITH THE SUBJECT DEVICE, THE POWER TURNED OFF AND ON SUDDENLY. THE USER REPLACED THE SUBJECT DEVICE WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE SUBJECT DEVICE WAS RETURNED TO THE OLYMPUS LOCAL SERVICE DEPARTMENT. THE OLYMPUS LOCAL SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON COULD NOT BE DUPLICATED. IT WAS REPORTED THAT THE SUBJECT DEVICE WAS RETURNED TO THE CUSTOMER BECAUSE IT PASSED THE INSPECTIONS. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588642 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1