BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 ELECTRONIC GAS BLENDER

    MDR report key: 20977757 · Received December 19, 2024

    Report

    Report Number
    9611109-2024-00625
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 28, 2024
    Report Date
    February 21, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. D.4 UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS NOT AVAILABLE FOR THIS PRODUCT AS IT IS A CLASS II MEDICAL DEVICE MANUFACTURED BEFORE SEPTEMBER 24, 2016 WHICH IS THE FDA COMPLIANCE DATE TO IMPLEMENT UDI CODE. G.5. THE S3 ELECTRONIC GAS BLENDER IS NOT DISTRIBUTED IN THE USA, AND IT IS SIMILAR TO S5 ELECTRONIC GAS BLENDER, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K101046). H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE S3 GAS BLENDER SYSTEM. THE EQUIPMENT WAS NOT IN USE AND WILL NOT BE REPAIRED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP COMMUNICATIONS WITH LIVANOVA TECHNICAL SERVICE CONFIRMED THE DEVICE WAS DEEMED NOT REPAIRABLE BECAUSE OF ITS AGE, AND WAS THUS REMOVED FROM SERVICE. A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE UNIT WAS MANUFACTURED IN 2005 AND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED. BASED ON SIMILAR INVESTIGATIONS, THE FOLLOWING FACTORS MAY CONTRIBUTE TO THE E15 (AN ISSUE WITH THE INTERNAL REFERENCE VOLTAGE) ERROR: - FAULTY PROCESSOR BOARD - FAULTY DC SUPPLY BOARD - LOOSE ELECTRICAL CONNECTION. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT S3 ELECTRONIC GAS BLENDER UNITS IS DISPLAYING AN ALARM FAULT IN AD TRANSFORMER (E15). THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283157 S3 ELECTRONIC GAS BLENDER GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX LIVANOVA DEUTSCHLAND 25-40-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown