BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7961211 · Received October 12, 2018

    Report

    Report Number
    8010042-2018-00536
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    September 14, 2018
    Report Date
    October 23, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    OUR INVESTIGATION FOR THE COMPLAINT IS FINALIZED. THE VENTILATOR SYSTEM WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE) ON SITE. THE FSE COULD NOT DUPLICATE THE REPORTED ISSUE, DESPITE SIMULATED USE TESTING IN DIFFERENT VENTILATION MODES ON A TEST LUNG. DEVICE WAS RELEASED BACK FOR MEDICAL USE. BASED ON THE DEVICE LOG EVALUATION, THE VENTILATION WAS STARTED IN A PRESSURE CONTROL VENTILATION MODE AT TIME 15:02, ON THE 14 SEPTEMBER; IT IS CONSIDERED TO BE THE MATCHING EVEN DATE. SEVERAL CLINICAL ALARMS WERE GENERATED INDICATING INSUFFICIENT OR POOR VENTILATION DURING THE WHOLE VENTILATION PERIOD THAT WAS TERMINATED ON 14 OF SEPTEMBER AT TIME 15:16. THE LOG ALSO INCLUDES ALARM FOR GAS SUPPLY PRESSURE LOW AT TIME 15:14 AND ONE ALARM FOR APNEA AT TIME 15:15. THE LOG CONFIRMS THAT THE PRE-USE CHECK WAS NOT PERFORMED BEFORE THE CASE WAS STARTED AND THAT IT WAS SUCCESSFULLY PERFORMED ON THE 26TH OF SEPTEMBER. THE TECHNICAL LOG DOES NOT CONTAIN ANY ERRORS/RECORDINGS RELATED TO THE REPORTED ISSUE, THIS INDICATES THAT THE DEVICE WAS WORKING AS EXPECTED. BASED ON THE CLINICAL ALARMS, THERE MAY HAVE BEEN A LEAKAGE IN THE PATIENT BREATHING SYSTEM/CONNECTIONS, OR THAT THE DEVICE PARAMETER WAS NOT CORRECTLY SETUP BY THE USER. THE ISSUE IS ATTRIBUTED TO USER ERROR. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED TO VENTILATE, DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #: CC-CPL-2018-01532. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799742 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1