BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 SYSTEM

    MDR report key: 7352402 · Received March 20, 2018

    Report

    Report Number
    9611109-2018-00243
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 20, 2018
    Report Date
    March 20, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    UDI-DI
    04033817900900
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED ISSUE AND TRACED THE FAILURE TO A DEFECTIVE E/P PACK. THE TECHNICIAN WAS NOT ABLE TO SOLVE THE ISSUE IN THE FIELD. THEREFORE THE DEFECTIVE DEVICE WAS RETURNED TO LIVANOVA (B)(4) FOR FURTHER INVESTIGATION AND REPAIR. DURING THE INVESTIGATION THE REPORTED FAILURE COULD BE REPRODUCED AND TRACED BACK TO A DEFECTIVE HEK BOARD. AS ROOT CAUSE FAULTY SOLDERING JOINTS COULD BE IDENTIFIED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A ALL DISPLAY AND CONTROL MODULES OF A S5 SYSTEM WENT BLANK DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195625 S5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 48-50-00 04033817900900

    Patients

    Seq Age Sex Outcome Treatment
    1