FDA-Device2022-01-26Class II
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Covidien, LP
Hazard
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.
Sold states
The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.
Affected count
66 devices
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0514-2022Don't want to check this manually?
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