Adult Sotair Device 00Recalls & reported problems
Safebvm Corp. · The Sotair™ device is a universal safety accessory device that is compatible with all manual resuscitators and airway interfaces that have standard ISO 5356-1:2015 15/22 mm connections. The device connects in-line between the bag and the mask, endotracheal tube or other applicable adjunct. In use, when the provider squeezes the bag too forcefully, crossing the maximum flow-limiting safety threshold of air delivered (~ 55 liters-per-minute), the Sotair device’s valve will instantaneously close. The valve remains closed as long as the user is maintaining the force of an unsafe squeeze on the bag. Once the provider releases the grip on the resuscitator bag, the valve will rapidly return to its resting position allowing the user to resume resuscitation at a safe flow. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860006979607), received between Nov 29, 2024 and Nov 29, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Blocked Connection” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Blocked Connection1
Patient problems
- Unspecified Respiratory Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 29, 2024Blocked Connection; Blocked Connection
THIS IS A SUPPLEMENTAL REPORT TO A PREVIOUSLY SUBMITTED REPORT: 3024753104-2024-00001, TO UPDATE INVESTIGATION RESULTS WITH INFORMATION OBSERVED BY THE MANUFACTURER OF A DEVICE INVOLVED IN THE INCIDENT.
Patient problems: Unspecified Respiratory Problem
MAUDE report 20813429 ↗
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- Ventlab AF2142MBVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 death1 report
- Ventlab VN3100OBVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.