BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 7150463 · Received December 28, 2017

    Report

    Report Number
    8010047-2017-02153
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Report Date
    March 11, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    PK110294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED UHI-4 IS PLANNED TO RETURN TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION, HOWEVER THE UHI-4 IS NOT RETURNED TO OMSC YET, THEREFORE OMSC CANNOT EVALUATE THE UHI-4. 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. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE THE DEVICE EVALUATION RESULTS. THE REFERENCED UHI-4 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION. THE EVALUATION COULD CONFIRM THE USER¿S REPORT AND THE RECORDING THE ERROR LOG WHICH INDICATED THE DAMAGE OF THE HYDRAULIC LINE PRESSURE SENSOR. THERE WAS THE POSSIBILITY OF THE DAMAGE OF THE HYDRAULIC LINE PRESSURE SENSOR WAS ATTRIBUTED TO THE INAPPROPRIATE HANDLING BY THE USER, SUCH AS THE INGRESS OF THE LIQUID AND/OR HUMID AIR INTO THE UHI-4, EXCESSIVE IMPACT, AND SO ON, OR THE ACCIDENTAL BREAKAGE OF THE SENSOR. CONSEQUENTLY THE UHI-4 COULD NOT OPERATE CORRECTLY THEN IT CAUSED THE UNSPECIFIED BEEP SOUND. 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.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE UNSPECIFIED SURGERY, THE UNSPECIFIED BEEP SOUND WAS GENERATED AROUND THE UHI-4. HOWEVER ANY ALARM WAS NOT DISPLAYED ON THE FRONT PANEL OF THE UHI-4. THE FACILITY CHANGED THE UHI-4 TO THE OTHER UNSPECIFIED 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
    930054 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1