BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I

    MDR report key: 8616301 · Received May 16, 2019

    Report

    Report Number
    8010042-2019-00321
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 24, 2019
    Report Date
    May 12, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 PERON: (B)(4). H3 OTHER TEXT: NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN FINALIZED. WE HAVE NOT IDENTIFIED ANY TECHNICAL MALFUNCTIONS WITH THE REPORTED DEVICE. ETCO2 MEASUREMENTS WITH AN EXTRA EXTERNAL CAPNOMETER, BOTH IN CLINICAL AND LABORATORY SETTINGS HAVE DEMONSTRATED EQUAL VALUES OF ETCO2. HENCE, IT CAN BE CONCLUDED THAT THE ETCO2 MEASUREMENT IS CORRECT. THE DEVICE SHOWS VOLUME AND FLOW EXPRESSED AT BTPS ACCORDING TO STANDARD SINCE 2015 (ISO 80601-2-13 201.5.101.2). BEFORE THIS, VOLUMES AND FLOWS WERE EXPRESSED IN AP21 (AMBIENT PRESSURE AND TEMPERATURE 21 °C DRY GASES). THE CLINICAL CONSEQUENCE OF THIS CHANGE, AP21 TO BTPS, IS THAT THE VOLUME DELIVERED FROM THE DEVICE OUTLET NOW IS ABOUT 12% LESS. ANESTHETIST NOW SET HOW LARGE THE PATIENT¿S LUNG EXPANSION SHALL BE AND NOT WHICH VOLUME THE VENTILATOR SHALL DELIVER. IN THE CHAPTER GENERAL INFORMATION IN THE USER'S MANUAL IT IS STATED HOW FLOW AND VOLUMES ARE EXPRESSED. THE ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED, HOWEVER THERE ARE A FEW POSSIBLE CONTRIBUTING FACTORS TO THE DIFFERENCE BETWEEN MEASURED ETCO2 AND PACO2. WHILE SETTING THE TIDAL VOLUME FOR THE PATIENT, THE OPERATOR MIGHT NOT CONSIDER THE DIFFERENCE BETWEEN BTPS AND AP21 AND THAT THE EXTERNAL EQUIPMENT, E.G. TUBES, ARE ADDING EXTRA DEAD SPACE TO THE SYSTEM. OR THE SAMPLE POINT FOR ETCO2 IS NOT CLOSE TO THE ENDOTRACHEAL TUBE (WHICH MIGHT LEAD TO AN INCREASED DIFFERENCE BETWEEN ETCO2 AND PACO2). OUR CONCLUSION IS THAT THE DEVICE IS FUNCTIONING ACCORDING TO DESIGN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DIFFERENCE BETWEEN THE ANESTHESIA WORKSTATION MEASURED ETCO2 LEVEL AND THE BLOOD GAS MEASURED PCO2 LEVEL. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409403 FLOW-I GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1