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MADA MEDICAL PRODUCTS, INC.

MADA MEDICAL PRODUCTS, INC · Model 1635-1 · UDI-DI 00815160021082

CAN

510(k) clearances

646

Adverse events (23 deaths)

Recalls

113

Facilities

Description

A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cylinder, and is used to regulate the high pressure of the supply to a safe working pressure which is delivered to the patient requiring oxygen therapy and ensuring that the prescribed (set/dialed) dosage of O2 is maintained at an accurate level. It acts both as a pressure reduction device and an O2 saving device. Commonly known as an oxygen conserving regulator it may be designed to provide a bolus of O2 to the patient by metering the gas over the normal inspiration/expiration phases, thus conserving it.

Recalls

Date	Firm	Reason
2023-01-03	Western/Scott Fetzer Company	Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use wi
2021-10-16	Western/Scott Fetzer Company	VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
2021-10-16	Western/Scott Fetzer Company	VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
2021-10-16	Western/Scott Fetzer Company	VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
2018-05-08	Dynarex Corporation	The device is equipped with a dial that has an inaccurate flow rate indicator.
2015-10-08	Precision Medical, Inc.	These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter
2015-01-31	Western / Scott Fetzer Company	The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death.
2014-04-07	Western / Scott Fetzer Company	Separation events have occurred, including the VIPR separating from the Aluminum cylinder.
2013-03-08	Linde Gas North America Llc	A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
2012-11-16	Praxair Inc.	Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.

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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.