BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C30

    MDR report key: 7624895 · Received June 21, 2018

    Report

    Report Number
    8010042-2018-00302
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    June 12, 2018
    Report Date
    October 15, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    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 PERON: (B)(4). THE ANESTHESIA WORKSTATION WAS INVESTIGATED ON SITE AND THE N2O FRESH GAS MODULE WAS REPLACED AND RETURNED FOR INVESTIGATION. THE N2O FRESH GAS MODULE REGULATES THE INSPIRATORY N2O GAS FLOW TO THE PATIENT. AN EVALUATION OF THE LOGS CONFIRMS THE REPORTED EVENT. THE RETURNED N2O GAS MODULE WAS SIMULATED USE TESTED IN A REFERENCE ANESTHESIA WORKSTATION. THE REPORTED ISSUE WAS NOT REPRODUCED. A FAULT WITH THE N2O GAS MODULE MAY LEAD TO A HIGHER OR LOWER AMOUNT OF N2O AND/OR O2 GAS IN THE GAS MIXTURE THAN EXPECTED. WITHOUT HAVING BEEN ABLE TO REPRODUCE THE REPORTED ISSUE, WE ARE NOT ABLE TO DETERMINE THE TRUE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION GENERATED AN ALARM FOR LOW FIO2 DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468177 FLOW-I C30 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C30

    Patients

    Seq Age Sex Outcome Treatment
    1