BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 CONTROL PANEL MRP

    MDR report key: 7698657 · Received July 18, 2018

    Report

    Report Number
    9611109-2018-01091
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 18, 2018
    Report Date
    September 21, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE BOARD WAS RETURNED TO LIVANOVA (B)(4) FOR FURTHER INVESTIGATION. DURING THE EVALUATION THE REPORTED ISSUE COULD NOT BE CONFIRMED OR REPRODUCED. NO MALFUNCTION COULD BE IDENTIFIED DURING THE INTENSIVE TESTING AND DURING THE EVALUATION OF THE SERIAL READOUT. THE BOARD WORKED ACCORDING THE SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(6). THE S5 CONTROL PANEL (B)(4) IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE DEVICE 28-95-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K071318). LIVANOVA (B)(4) MANUFACTURES THE S5 CONTROL PANEL MRP. 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 REPRODUCE THE REPORTED ISSUE. THE DEVICE WORKED ACCORDING TO SPECIFICATION. HOWEVER, THE PROCESSOR BOARD WAS REPLACED AS A PRECAUTION DUE TO BEING AN OLDER VERSION. A SERIAL READOUT WAS PROVIDED FOR FURTHER INVESTIGATION. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE DISPLAY OF AN S5 CONTROL PANEL MRP BECAME BLANK DURING A PROCEDURE. THE CUSTOMER REPORTED THAT THE ISSUE WAS RESOLVED BY RESTARTING THE PANEL. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539479 S5 CONTROL PANEL MRP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND SM000015

    Patients

    Seq Age Sex Outcome Treatment
    1