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Equinox Relieve

O-Two Medical Technologies Inc · Model 01EQ1000 · UDI-DI 07540195040021

BZR Prescription

510(k) clearances

590

Adverse events (9 deaths)

Recalls

Facilities

Description

The Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device designed to provide a 50/50% nitrous oxide and oxygen mixture. It provides two input connectors for connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has only one control for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be activated by an inspiratory effort by the patient. The out put of N2O/O2 gas mixture is pre-set at 50/50%. Neither the patient nor medical personnel are able to adjust, eliminating the risk of delivering a hypoxic mixture.

Recalls

Date	Firm	Reason
2018-05-15	CAREstream Medical LLC	Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
2018-05-14	O-Two Medical Technologies, Inc.	Higher levels of nitrous oxide delivered than specification
2005-01-11	Maquet Inc	Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.

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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.