BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 CONSOLE

    MDR report key: 22025614 · Received May 15, 2025

    Report

    Report Number
    9611109-2025-90120
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 20, 2026
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    UDI-DI
    04033817902676
    PMA / PMN Number
    K210130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 CONSOLE PRO VERSION. THE INCIDENT OCCURRED IN INDIA. IN ORDER TO SOLVE THE ISSUE, MOTOR CONTROL BOARD (HMS) AND MOTOR POWER AMPLIFIER BOARD (HMF) NEED TO BE REPLACED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO REPLACE MOTOR CONTROL BOARD (HMS) AND MOTOR POWER AMPLIFIER BOARD (HMF), HOWEVER THE ISSUE REMAINED. DURING FURTHER TROUBLESHOOTING, IT WAS FOUND THAT THE ISSUE WAS WITH THE MOTOR SHAFT. THEREFORE, THE TWO NEW BOARDS WERE REMOVED, REINSTALLED THE OLD ONES AND SENT THE INVOLVED AFFECTED PUMP TO LIVANOVA DEUTSCHLAND FOR A FURTHER INVESTIGATION AND REPAIR. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 CONSOLE PRO VERSION GAVE A MOTOR CONTROL FAILURE ERROR MESSAGE (CODE 442) DURING PRIMING, AFTER INSTALLATION OF THE MACHINE. RESTARTING THE MACHINE AND RECONNECTING ALL CABLES DID NOT RESOLVE THE ISSUE. 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
    614566 S5 CONSOLE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 48-40-00Z 04033817902676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown