BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 7961748 · Received October 12, 2018

    Report

    Report Number
    8010042-2018-00545
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    October 2, 2018
    Report Date
    November 26, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(4). THE VENTILATOR WAS INVESTIGATED ON SITE AND THE O2 GAS MODULE AND AIR GAS MODULE WERE REPLACED AND RETURNED FOR INVESTIGATION. THE GAS MODULES REGULATE THE INSPIRATORY OXYGEN AND AIR GAS FLOW TO THE PATIENT. THE REPORTED ALARM FOR O2-CONCENTRATION FLUCTUATION WAS NOT REPRODUCED DURING SIMULATED TEST OF THE RETURNED O2 GAS MODULE AND AIR GAS MODULE IN A VENTILATOR. DURING TESTS IN THE PRODUCTION TEST SYSTEM FOR GAS MODULES THERE WAS A MINOR DEVIATION IN THE O2 GAS MODULE, PROBABLY A DRIFT IN THE ELECTRONICS ON ONE OF THE BOARDS INSIDE THE O2 GAS MODULE. THE AIR GAS MODULE WAS FOUND FAULTLESS. IF THIS FAULT HAPPENS DURING VENTILATION, THE PATIENT MAY RECEIVE AN AMOUNT OF OXYGEN IN THE GAS MIXTURE THAT DEVIATE FROM THE EXPECTED. FLOW AND PRESSURE MAY ALSO DEVIATE FROM THE EXPECTED. ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS NO MATCHING EVENT, SINCE THE RECEIVED DEVICE LOGS WERE CAPTURED BEFORE THE REPORTED EVENT DATE. OUR CONCLUSION INTO THIS MATTER IS THAT THE MINOR DEVIATION FOUND IN THE PRODUCTION TEST SYSTEM IS NOT LIKELY THE CAUSE OF REPORTED EVENT. THE REPORTED PROBLEM COULD NOT BE REPRODUCED, THEREFORE THE CAUSE COULD NOT BE DETERMINED IN THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE O2 CONCENTRATION WAS FLUCTUATING DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799786 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1