RT’s Three Key Takeaways:
- The US Meals and Drug Administration has recognized the recall of the SonarMed airway monitoring system’s sensors as a category I recall, which is essentially the most severe sort.
- Using the affected SonarMed sensors can result in severe antagonistic well being penalties, together with delays in remedy, low oxygen ranges, air leaking into the chest cavity, hurt to tissues, gradual coronary heart fee, and probably respiratory failure.
- Medtronic, on behalf of SonarMed Inc, has suggested all affected clients to discontinue use of the sensors and to quarantine all SonarMed airway system merchandise.
Medtronics’ SonarMed Inc is recalling its SonarMed airway acoustic sensors—used with the SonarMed airway monitoring system—attributable to a restricted inside diameter leading to problem passing a suction catheter via the sensor.
Use of the affected SonarMed sensors might trigger severe antagonistic well being penalties, together with delays in remedy, low oxygen ranges, air leaking into the chest cavity, not sufficient air reaching the lungs, hurt to the tissues, gradual coronary heart fee, or respiration issues resulting in respiratory failure.
On March 25, Medtronic, on behalf of SonarMed Inc, despatched all affected clients an Pressing Medical Gadget Recall discover advising them on subsequent steps, together with discontinuing use of affected sensors and quarantining all SonarMed airway system merchandise.
There was one reported harm. No deaths have been reported. The US Meals and Drug Administration (FDA) has recognized this as a category I recall, essentially the most severe sort of recall.
Gadget Use
The SonarMed airway monitoring system consists of a SonarMed monitor used along side a single-patient-use SonarMed sensor linked through an exterior cable and software program that operates the monitor and sensor.
When in use, the SonarMed AirWave airway sensor is positioned in-line between the ventilator circuit and the proximal finish of the endotracheal tube (ETT) of a affected person who’s linked to a ventilator. The Sensor replaces the usual 15-mm connector (also called the hub) that comes with the ETT and makes use of acoustic reflection know-how to supply real-time info to clinicians. This contains the baseline location of the ETT tip, estimation of passageway dimension across the tip, detection of ETT motion, and identification of occlusions or obstructions.
The SonarMed airway monitoring system is meant to be used by educated medical professionals to assist the administration of synthetic airways in hospital settings akin to intensive care models, working rooms, emergency departments, and through intrahospital transport. It’s meant to enrich normal medical practices and isn’t supposed as a standalone diagnostic instrument.
The system is appropriate to be used throughout a variety of sufferers, together with neonates, infants, youngsters, adolescents, and adults, protecting a dimension vary from 2.5 mm to 9 mm for endotracheal tubes.
Recalled Product
- Product names: SonarMed Airway acoustic sensors
- Product codes: OQU
- Mannequin numbers: AW-S025, AW-S030, AW-S035
- Distribution dates: Oct 12, 2022, to Aug 11, 2023
- Units Recalled within the US: 1,800
- Date Initiated by Agency: March 21
Who Could also be Affected
- Well being care suppliers who use the SonarMed airway monitoring system to assist the administration of synthetic airways.
- Individuals who obtain care with the SonarMed airway monitoring system. The system is meant to be used by educated medical professionals to assist the administration of synthetic airways.
What to Do
Well being care professionals and shoppers might report antagonistic reactions or high quality issues they skilled utilizing these gadgets to MedWatch: The FDA Security Info and Hostile Occasion Reporting Program utilizing an internet type, common mail, or FAX.
Prospects within the US with questions on this recall ought to contact a Medtronic consultant or customer support at 800-962-9888, possibility 2.
Extra info could be discovered on the FDA’s web site.
Picture caption: SonarMed airway monitoring system
Picture credit score: Medtronic
