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o_two CPAP

O-Two Medical Technologies Inc · Model 01CV0222 · UDI-DI 07540195035102

BYE Prescription

510(k) clearances

254

Adverse events (34 deaths)

Recalls

Facilities

Description

The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients. The adjustment of the CPAP level is achieved by adjusting the output flow from oxygen therapy regulator or wall outlet. The setting selections noted on the device provide an accurate constant airway pressure at each flow setting.

Recalls

Date	Firm	Reason
2019-01-15	Westmed, Inc.	A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with i
2019-01-15	Westmed, Inc.	A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with i
2019-01-15	Westmed, Inc.	A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with i
2015-09-24	Airways Development LLC	Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determined if this was an is
2008-03-04	Smiths Medical ASD, Inc.	Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of ai
2008-03-04	Smiths Medical ASD, Inc.	Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of ai
2007-08-21	Ambu Incorporated	Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
2007-08-21	Ambu Incorporated	Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
2007-08-21	Ambu Incorporated	Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
2007-08-21	Ambu Incorporated	Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.

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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.