BEUDAMED
    FDA Enforcement Class I Terminated

    Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.

    Recall: Z-0804-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0804-2016
    Event ID
    73137
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular Us Sales, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    December 10, 2015
    Classification Date
    February 22, 2016
    Termination Date
    July 6, 2016
    Address
    45 Barbour Pond Drive, N/A, Wayne, NJ, 07470, United States

    Description

    Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.

    Reason

    Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US.

    Code Info

    Model numbers: C20, C30 and C40 (Only Model # C20 for US) Part numbers: 66 77 200 (US Only), 66 77 300 and 66 77 400 Serial numbers (2743, 2852, 2854, 2855, 2856, 2858

    Distribution

    US Nationwide in the states of CA, NY, and OR

    Quantity

    7 units within US