BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 7436194 · Received April 17, 2018

    Report

    Report Number
    8010042-2018-00188
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    October 10, 2017
    Report Date
    May 4, 2018
    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 PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE COMPANY FIELD SERVICE ENGINEER VISITED THE HOSPITAL AND INVESTIGATED THE ANESTHESIA WORKSTATION. THE FRESH GAS SAFETY VALVE WAS REPLACED AND RETURNED FOR INVESTIGATION. THE RETURNED FRESH GAS SAFETY VALVE HAS BEEN SIMULATED USE TESTED IN REFERENCE ANESTHESIA WORKSTATION. THE FRESH GAS SAFETY VALVE FUNCTIONED AS INTENDED. THE REPORTED ISSUE WITH A LOWER OXYGEN CONCENTRATION THAN SET COULD NOT BE REPRODUCED. THE DEVICE LOGS FROM THE REPORTED EVENT HAVE BEEN REQUESTED BUT WERE NOT RECEIVED. WE HAVE NOT BEEN ABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUES. 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 ANESTHESIA WORKSTATION GENERATED ALARMS FOR LOW FRACTION OF INSPIRED O2. THERE WAS NO PATIENT HARM REPORTED. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281026 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1