Airway Monitoring System
Anesthesiology · 21 CFR 868.5730
The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip
Recent MDR events
7 adverse event reports on file
- SONARMEDSep 17, 2024MalfunctionSonarmed, Inc.1282497-2024-00392
- SONARMEDSep 17, 2024MalfunctionSonarmed, Inc.1282497-2024-00393
- SONARMEDMar 11, 2024MalfunctionSonarmed, Inc.1282497-2024-00025
- SONARMEDMar 11, 2024MalfunctionSonarmed, Inc.1282497-2024-00026
- SONARMEDMar 11, 2024MalfunctionSonarmed, Inc.1282497-2024-00027
- SONARMEDMar 11, 2024MalfunctionSonarmed, Inc.1282497-2024-00028
- SONARMEDMar 11, 2024MalfunctionSonarmed, Inc.1282497-2024-00029
Event type breakdown
Most-reported manufacturers
Recalls
6 recall events for this product code
- SonarMed IncOpen, ClassifiedApr 19, 2024
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Z-1535-2024 · View FDA record ↗ - SonarMed IncOpen, ClassifiedApr 18, 2024
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
Z-1519-2024 · View FDA record ↗ - SonarMed IncOpen, ClassifiedApr 18, 2024
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
Z-1520-2024 · View FDA record ↗ - SonarMed IncOpen, ClassifiedApr 18, 2024
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
Z-1521-2024 · View FDA record ↗ - Covidien, LPOpen, ClassifiedUnknown
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
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.
Z-0514-2022 · View FDA record ↗ - SonarMed IncTerminatedUnknown
SonarMed AirWave Monitor, Model Number M0001
Potential for the presence of two error codes which would make the monitor inoperable.
Z-2450-2019 · View FDA record ↗
Registered firms
2 firms currently registered for this product code