BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 7666079 · Received July 6, 2018

    Report

    Report Number
    8010042-2018-00326
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    June 25, 2018
    Report Date
    September 4, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    THE COMPANY REPRESENTATIVE INVESTIGATED THE ANESTHESIA WORKSTATION,(HERE AFTER REFERRED TO AS ¿THE SYSTEM¿). NO FAULTS WERE FOUND. THE ADDITIONAL FRESH GAS OUTLET VALVE (AFGO) WAS REPLACED AS A PREVENTIVE MEASURE SINCE THE PROBLEM DESCRIPTION STATED THAT THE USER EXPERIENCED ISSUES WITH GETTING ANY GAS OUT OF THE AFGO. THE SYSTEM HAS REPORTEDLY BEEN RETURNED INTO CLINICAL USE WITHOUT ANY ISSUES EVER SINCE. THE REPLACED AFGO VALVE WAS RECEIVED FOR INVESTIGATION AS WELL AS THE DEVICE LOGS FROM THE EVENT DATE. THE AFGO VALVE CAN BE SET TO DELIVER FLOW TO EITHER THE AFGO OUTLET OR TO THE PATIENT CASSETTE. DURING TEST BENCH LEAKAGE TESTS, A LEAKAGE ALLOWED A SMALL AMOUNT OF THE FRESH GAS TO LEAK INTO INSPIRATORY CHANNEL(PATIENT CASSETTE POSITION). A COMPLETE DISMOUNTING OF THE AFGO VALVE WAS DONE AND AN O-RING LOCATED ON THE PISTON SHOWED SIGNS OF WEAR THAT COULD EXPLAIN THE LEAKAGE. SYSTEM CHECK OUT PASSED PRIOR TO AND AFTER THE EVENT. THERE ARE NO RECORDINGS IN THE TECHNICAL LOG RELATED TO THE REPORTED ISSUE. WE CANNOT WITH CERTAINTY CONFIRM THE REPORTED IN THE RECEIVED EVENT LOG AND THE TREND LOG. THE LEAKAGE FOUND IN THE AFGO VALVE WOULD NOT ALONE EXPLAIN THE LACK OF FLOW EXPERIENCED BY THE USER. AN ADDITIONAL CAUSE/ISSUE WHICH WE HAVE BEEN UNABLE TO IDENTIFY IS LIKELY TO HAVE BEEN PRESENT AT THE TIME OF THE EVENT. WE HAVE NOT BEEN ABLE TO DETERMINE THE TRUE CAUSE OF THE EXPERIENCED EVENT. 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 DURING PATIENT TREATMENT, THE PERSONNEL WAS UNABLE TO GET ANY GAS OUT OF THE ADDITIONAL FRESH GAS OUTLET (AFGO) AFTER SELECTING IT AND SELECTING THE FLOW. IT WAS FURTHER REPORTED THAT THE PATIENT'S SATURATION DROPPED. FINAL PATIENT OUTCOME WAS REPORTED TO BE NO INJURY. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE#:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509673 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening