BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN S5 SYSTEM

    MDR report key: 20201489 · Received September 12, 2024

    Report

    Report Number
    9611109-2024-00418
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 16, 2024
    Report Date
    November 28, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DTQ
    UDI-DI
    04033817900894
    PMA / PMN Number
    K071318
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 SYSTEM. A LIVANOVA FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER. AUDIBLE ALARM ON THE ROOM ISOLATION TRANSFORMER. AFTER REPLACING THE SWITCH, S5 MAINS CABLE, S5 UPS MODULE AND DC/DC MODULE AND LEAVING THE EQUIPMENT CONNECTED TO THE NETWORK FOR 24 HOURS, THE ACOUSTIC ALARM DISAPPEARED. PERFORMED CEI STANDARD CHECKS. EQUIPMENT ALSO PLACED AT PREVENTIVE ANNUAL MAINTENANCE WITH SENSOR CONTROL. UNIT RETURNED TO CUSTOMER. 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 DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE UNIT WAS MANUFACTURED IN 2018 AND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED. BASED ON THE COLLECTED INFORMATION, THE CAUSE OF THE ISSUE HAS BEEN TRACED BACK TO A FAILURE OF INTERNAL COMPONENTS.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT WHEN THE SORIN S5 SYSTEM IS PLUGGED IN, IT TRIGGER THE OPERATION ROOM ALARM. THE ISSUE OCCURRED DURING MAINTENANCE AND 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
    1584558 SORIN S5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND GMBH 48-40-00 04033817900894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown