BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOW-I C20

    MDR report key: 7743457 · Received August 2, 2018

    Report

    Report Number
    8010042-2018-00398
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    June 28, 2018
    Report Date
    October 1, 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
    BIOMEDICAL ENGINEER

    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 PERSON: (B)(6). NO FAULT WAS FOUND WHEN THE DEVICE WAS EXAMINED AT THE HOSPITAL. THERE ARE NO TECHNICAL ERRORS/ALARMS IN THE RECEIVED DEVICE LOGS. SYSTEM CHECK OUT PASSED PRIOR TO AND AFTER THE EVENT. THE TREND LOG CONTAINS NO DATA SINCE THE LOGS WERE SAVED MORE THAN 24 HOURS AFTER THE EVENT. THE INTERNAL LOG SHOWS THAT THE PATIENT WAS VENTILATED WITHOUT HAVING ANY SEVOFLURANE ADDED TO THE FRESH GAS. THE VAPORIZER WAS EITHER SET TO OFF (IN MANUAL VENTILATION) OR NO TARGET VALUE WAS SELECTED IN AGC. APART FROM THIS, THERE IS NOTHING ELSE THAT WOULD EXPLAIN THE REPORTED LACK OF AGENT DELIVERY. IF THE VAPORIZER WOULD HAVE BEEN SHUT DOWN BY ITSELF OR BY THE SYSTEM, ALARMS/TECHNICAL ERRORS WOULD HAVE BEEN GENERATED. OUR CONCLUSION BASED ON THE DEVICE LOG EVALUATION AND THE RECEIVED INFORMATION IS THAT THE REPORTED EVENT, THAT THE ANESTHESIA SYSTEM DIDN¿T DELIVER SEVOFLURANE, IS RELATED TO THE USER AND NOT A TECHNICAL FAILURE IN THE ANESTHESIA SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE BEGINNING OF THE SURGERY WHEN THE PROCEDURE HAD STARTED THE PATIENT STARTED TO MOAN AND MOVE ARMS. THE PATIENT PULLED THE LMA (LARYNGEAL MASK AIRWAY) OUT. THE PATIENT WAS ADMINISTERED AN ANESTHETIC AGENT AND WAS RE-INTUBATED. THE PATIENT AWARENESS LEVEL INCREASED AND AWOKE. THE FINAL PATIENT OUTCOME WAS NO INJURY. 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
    585499 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other