BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVALUNG CONSOLE (LINUX BOARD)

    MDR report key: 12796717 · Received November 11, 2021

    Report

    Report Number
    3012172416-2021-00040
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    May 4, 2021
    Report Date
    November 11, 2021
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: INVESTIGATION OF THE MACHINE FILES IS NOT CONSIDERED NECESSARY BECAUSE THE COMPLAINT IS RELATED TO A COMPONENT DEFECT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. NO DEVIATIONS WERE FOUND DURING THE DEVICE HISTORY RECORD (DHR) REVIEW. HOWEVER, IT WAS FOUND THAT THE SENSOR BOX INCLUDES COMPONENTS WITH A PROBLEMATIC MATERIAL COMBINATION. AN IMPROPER CONTACT PLATING BETWEEN THE CABLE HARNESS AND FLOW SENSOR BOARD CAN REDUCE THE ELECTRICAL CONDUCTIVITY OF THE CONNECTION BY FRETTING AND GALVANIC CORROSION, WHICH CREATES A VOLTAGE DROP RESULTING IN COMMUNICATION INTERRUPTIONS. A SUPPLIER CHANGED THE CONNECTOR P102 MATERIAL, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE CHANGE WAS INITIATED BECAUSE OF A DISCONTINUATION OF PRINTED CIRCUIT BOARD (PCB) COMPONENTS. THE COMMUNICATION INTERRUPTION MAY BE CAUSED BY AN INCREASE IN ELECTRICAL RESISTANCE DUE TO A CONNECTOR WITH MIXED COATING MATERIALS. A CONNECTOR WITH MIXED COATING MATERIALS (IN THIS CASE GOLD AND TIN) MAY LEAD TO OXIDATION (FRETTING EFFECT) ON THE CONNECTION SURFACE OVER TIME INCREASING THE ELECTRICAL CONTACT RESISTANCE (AT P102). THE ERROR MESSAGES 206 AND 208 IMPLY THAT THE COMMUNICATION BETWEEN THE FLOW SENSOR AND SENSOR BOX WAS INTERRUPTED. AN INTERRUPTED COMMUNICATION BETWEEN THE FLOW SENSOR AND SENSOR BOX CAN RESULT IN DISABLED FLOW MEASUREMENT AND AIR BUBBLE DETECTION. THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU). IF ALARM 208 IS CONTINUOUSLY ALARMING, THE IFU PROVIDES INSTRUCTIONS TO REPLACE THE MACHINE. BASED ON THE FINDINGS OF THE INVESTIGATION, THE REPORTED EVENT HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO TECHNICAL SERVICE THAT A FLOW MEASUREMENT FAILURE OCCURRED, WITH ERROR CODE 206/208. THE SENSOR BOX WAS REPLACED, AND THIS RESOLVED THE REPORTED ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT AS THE ERROR OCCURRED DURING PREPARATION OF THE CONSOLE. IT WAS UNKNOWN IF THE PROBLEM RESULTED IN ANY DELAYED OR MISSED TREATMENTS. THE SENSOR BOX WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697172 NOVALUNG CONSOLE (LINUX BOARD) QJZ QJZ XENIOS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown