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Heroic Faith International Ltd. · Model Airmod · UDI-DI 04719882170119

BZQ Prescription

510(k) clearances

127

Adverse events (11 deaths)

Recalls

112

Facilities

Description

Airmod is an Android-based software application designed to aid healthcare professionals by monitoring a patient’s breathing in real time. It can detect inhalation acoustics and provides respiratory rates based on the analysis of the acoustic signals of breathing sounds collected by AccurSound Electronic Stethoscope AS-101. Airmod is intended for the continuous monitoring of respiratory rate (RR) in adults who are subjected to procedural sedation in which the depth of sedation ranges from moderate and deep sedation/anesthesia to general anesthesia and the consciousness status of patients ranges from clear to unarousable. Airmod is designed for use in hospitals and healthcare facilities performing procedural sedation/anesthesia.

Recalls

Date	Firm	Reason
2010-12-21	Salter Laboratories, Division of Regulatory Affairs	The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment.
2004-06-04	Respironics, Inc.	Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
2004-05-24	CAS Medical Systems, Inc.	Device may not alarm for %SpO2 value limit violations if a specific feature is enabled

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.