BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 10702950 · Received October 20, 2020

    Report

    Report Number
    8010047-2020-07876
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Report Date
    October 20, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    UDI-DI
    04953170140297
    PMA / PMN Number
    K014166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. OLYMPUS LOCAL SERVICE ENGINEER REPORT THAT THE POWER SUPPLY UNIT OF THE DEVICE WAS BROKEN. OMSC SURMISED THAT THE REPORTED PHENOMENON WAS OCCURRED DUE TO THE POWER SUPPLY UNIT OF THE DEVICE WAS BROKEN BY SOME CAUSE. THE INSTRUCTION MANUAL OF THE DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE DEVICE COULD NOT BE TURNED THE POWER ON. 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
    1168619 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-3 04953170140297

    Patients

    Seq Age Sex Outcome Treatment
    1