BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 8045065 · Received November 6, 2018

    Report

    Report Number
    8010047-2018-02134
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Report Date
    March 11, 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

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2018-02134. THE SUBJECT UHI-4 NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). OMSC CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT DEVICE, AND THERE WAS NO IRREGULARITY FOUND. THE LOCAL ENGINEER REPORTED THE FOLLOWING INSPECTION RESULT OF THE SUBJECT UHI-4. -THE REPORTED PHENOMENON WAS NOT REPRODUCED. -THE LOG DATA OF THE SUBJECT UHI-4 SHOWED NO ERRORS OR DROPOUTS. -THE "CAVITY MODE" OF THE SUBJECT UHI-4 WAS SET TO SMALL. SINCE THE EVENT WAS NOT REPRODUCED, THE EXACT CAUSE HAS BEEN UNKNOWN; HOWEVER, THE FOLLOWING ARE SUPPOSED TO BE THE CAUSE. - THE SUBJECT DEVICE SETTING AND/OR USER HANDLING. - THE PATIENT¿S CONDITION. THE INSTRUCTION MANUAL OF THE UHI-4 STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE SUBJECT UHI-4 NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING THE UNSPECIFIED PROCEDURE WITH THE UHI-4, THE SUBJECT UHI-4 COULD NOT SUPPLY CO2 TO THE PATIENT. THE USER CANCELED THE UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF THE PATIENT INJURY OTHER THAN ABOVE. THE LOCAL ENGINEER REPORTED THE FOLLOWING INSPECTION RESULT OF THE SUBJECT UHI-4. -THE REPORTED PHENOMENON WAS NOT REPRODUCED. -THE LOG DATA OF THE SUBJECT UHI-4 SHOWED NO ERRORS OR DROPOUTS. -THE "CAVITY MODE" OF THE SUBJECT UHI-4 WAS SET TO SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881123 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1