BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 7636545 · Received June 25, 2018

    Report

    Report Number
    8010047-2018-01219
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Report Date
    March 13, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K110294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCED UHI-4 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION. OMSC EVALUATED THE UHI-4 AND FOUND THAT THERE WAS NO ABNORMALITY AND IRREGULARITY AND COULD NOT CONFIRM THE USER¿S REPORT. ALSO THE UHI-4 DID NOT RECORD ANY ERROR LOG. THE EXACT CAUSE OF THIS PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE WAS THE POSSIBILITY OF THIS PHENOMENON WAS ATTRIBUTED TO THE DECREASE OF THE FLOW DUE TO PARTIALLY CLOGGED TUBE AND/OR THE INAPPROPRIATE SETTING OF THE UHI-4, OR THE USAGE ENVIRONMENT OF THE FACILITY, SUCH AS THE TEMPORARY MALFUNCTION DUE TO THE NOISE AND/OR STATIC ELECTRICITY. CONSEQUENTLY THERE WAS THE POSSIBILITY THE ERROR CAUSED THAT THE UHI-4 COULD NOT OPERATE CORRECTLY. OLYMPUS STATED THE APPROPRIATE HANDLING OF UHI-4 AND THE COUNTER MEASURES AGAINST ABNORMALITIES IN THE INSTRUCTION MANUAL OF UHI-4. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE REFERENCED UHI-4 HAS BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION, HOWEVER THE EVALUATION IS IN PROGRESS AT THIS TIME. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING UNSPECIFIED PROCEDURE, THE CAVITY PRESSURE DECREASED SUDDENLY AND THE INSUFFLATION FROM THE UHI-4 WAS STOPPED. THE FACILITY CHANGED THE UHI-4 TO THE OTHER SIMILAR DEVICE 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
    475091 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1