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Nihon Kohden

NIHON KOHDEN ORANGEMED, INC. · Model MSK3316P · UDI-DI 00843685100173

MNT Prescription

510(k) clearances

48,295

Adverse events (248 deaths)

Recalls

Facilities

Description

The NPPV cap-ONE Mask Set (Extra Small) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient.

Recalls

Date	Firm	Reason
2025-05-09	Philips Respironics, Inc.	This device does not indicate for use in patients with respiratory failure.
2024-03-26	Philips Respironics, Inc.	Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, res
2023-08-25	Philips Respironics, Inc.	Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
2023-05-15	DRE Medical Group Inc	Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.
2022-02-28	Respironics California, LLC	Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
2022-02-28	Respironics California, LLC	Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
2022-02-28	Respironics California, LLC	Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
2022-01-24	Respironics California, LLC	A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the
2022-01-24	Respironics California, LLC	A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the
2021-06-18	Respironics California, LLC	It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of press

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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.