BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 GAS BLENDER SYSTEM

    MDR report key: 6953553 · Received October 16, 2017

    Report

    Report Number
    9611109-2017-00819
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    September 20, 2017
    Report Date
    December 7, 2017
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN SENT TO LIVANOVA (B)(4) FOR FURTHER EVALUATION. DURING THE INTERNAL INVESTIGATION, THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE DEVICE UNDERWENT A ROUTINE MAINTENANCE AND A VALUE ADJUSTMENT AND IT WAS THEN RETURNED TO THE CUSTOMER BY LIVANOVA (B)(4). AS THE ISSUE COULD NOT BE REPRODUCED OR CONFIRMED, A ROOT CAUSE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE S3 GAS BLENDER 25-40-00 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO S5 GAS BLENDER SYSTEM 25-40-45, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K101046). LIVANOVA (B)(4) MANUFACTURES THE S3 GAS BLENDER SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS UNABLE TO CONFIRM THE REPORTED ISSUE. THE DEVICE WAS TESTED WITHOUT A FAILURE. THE DEVICE HAS BEEN SENT TO LIVANOVA (B)(4) FOR FURTHER EVALUATION. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE O2 SUPPLY OF THE S3 GAS BLENDER SYSTEM DROPPED DURING A PROCEDURE. THE TECHNICIAN USED AN O2 BOTTLE TO CONTINUE OXYGEN FLOW AND PREVENT PATIENT INJURY. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732744 S3 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX LIVANOVA DEUTSCHLAND 25-40-00

    Patients

    Seq Age Sex Outcome Treatment
    1