BEUDAMED
    FDA Recall Open, Classified

    SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)

    Recall: Z-0514-2022 · Initiated December 22, 2021

    Recall

    Recall Number
    Z-0514-2022
    Event Number
    89283
    FEI Number
    1219930
    Product Code
    OQU
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 22, 2021
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)

    Reason

    Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.

    Action

    Urgent Medical Device Recall were distributed to customers beginning 12/22/21. Actions you should take: " Immediately discontinue use of the affected SonarMed AirWave" monitors. Remove the affected devices listed on Attachment A from clinical service. " Notify all personnel in all care environments in which the affected SonarMed AirWave" monitors are used about this medical device recall. " If your facility has distributed affected SonarMed AirWave" monitors to other persons or facilities, please promptly forward a copy of this letter to those recipients. " Complete the attached Recalled Product Return Form even if you do not have inventory. " Customers are requested to return the item codes listed on Attachment A as described in this notice. Actions being taken by Medtronic: " Medtronic is implementing manufacturing process improvements to address the manufacturing assembly issue and is developing a software update to address the identified software anomaly. This software is projected to be available in Spring 2022 and will be factory installed on all newly manufactured SonarMed AirWave" monitors. Purchased directly from Medtronic: Customer with inventory: 1. Complete the Recalled Product Return Form and fax or email to Medtronic. 2. Ship affected product with Retuned Goods Authorization (RGA) number provided by Customer Service to: Medtronic Attn: Field Returns 195 McDermott Road North Haven, CT 06473. Customer with zero inventory: Complete form and check the box indicating no inventory and fax or email to Medtronic. Where to send the completed form: Fax to 800-895-6140 or email to [email protected] Credit for returned affected product will be issued based on the RGA number. Exception: Customers with zero inventory, fax to 651-367-2624 or email to [email protected] Purchased from a distributor: Customer with inventory: 1. Complete the Recalled Product Return Form and fax or email to Medtron

    Distribution

    The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.

    Quantity

    66 devices