Ventilator, Continuous, Non-life-supporting
Anesthesiology · 21 CFR 868.5895
Recent MDR events
11,195 adverse event reports on file
- BiPAP A30, InternationalJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040822
- BiPAP A30, InternationalJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040834
- BiPAP A30Jul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040802
- BiPAP A30, GermanyJul 30, 2026MalfunctionRespironics, Inc.2518422-2026-040290
- BiPAP A30-S, GermanyJul 30, 2026MalfunctionRespironics, Inc.2518422-2026-040523
- BiPAP A30-S, GermanyJul 30, 2026MalfunctionRespironics, Inc.2518422-2026-039998
- BiPAP A30, InternationalJul 30, 2026MalfunctionRespironics, Inc.2518422-2026-040540
- BiPAP A30, GermanyJul 30, 2026MalfunctionRespironics, Inc.2518422-2026-040521
- BiPAP A30Jul 30, 2026MalfunctionRespironics, Inc.2518422-2026-040558
- BiPAP A30, GermanyJul 30, 2026MalfunctionRespironics, Inc.2518422-2026-040572
Event type breakdown
Recalls
21 recall events for this product code
- BMC Medical Co., Ltd.Open, ClassifiedAug 19, 2026
BMC/REACTHEALTH
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
Z-2979-2026 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedJul 2, 2025
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
This device does not indicate for use in patients with respiratory failure.
Z-2035-2025 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedJul 2, 2025
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg.
This device does not indicate for use in patients with respiratory failure.
Z-2036-2025 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedMay 24, 2024
BiPAP V30 Auto Ventilator, Part Number 1111178
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Z-1812-2024 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedMay 24, 2024
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS)
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Z-1814-2024 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedMay 23, 2024
OmniLab Advanced + Ventilator
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
Z-1817-2024 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedSep 9, 2022
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Z-1654-2022 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedSep 9, 2022
Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Z-1655-2022 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedSep 9, 2022
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficie
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Z-1656-2022 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedSep 9, 2022
Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insuffi
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Z-1657-2022 · View FDA record ↗
Registered firms
95 firms currently registered for this product code
Ceva Logistics Limited
Daventry Northamptonshire, GB
Philips Electronics Ltd
Mississauga Ontario, CA
Inventus Power, Inc.
Dongguan City P.R. Guangdong, CN
Resmed Asia Pte. Ltd.
Singapore South West, SG
Resmed Corp
San Diego, CA, US
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Bmc Medical Co., Ltd.
Fengtai District Beijing, CN
Respironics, Inc.
Mount Pleasant, PA, US
Respironics Inc.
MURRYSVILLE, PA, US
Respironics Deutschland Gmbh & Co.kg
Herrsching Bavaria, DE
Respironics, Inc.
New Kensington, PA, US
Resmed Pty Ltd.
BELLA VISTA New South Wales, AU
3b Medical Inc
Dublin, OH, US
Breas Medical, Inc.
N Billerica, MA, US
Philips Global Business Services Llp
Baner Pune Maharashtra, IN
510(k) clearances
47 clearances for this product code
- Resmed CorpApr 8, 2026
K251889 · myAir
- Compal Electronics, Inc.Mar 17, 2026
K252078 · BreathePal Bilevel (GFM50-MD2201)
- Resmed Pty , Ltd.Feb 23, 2026
K251661 · Mariana Minerva; Mariana Nimbus
- Breas Medical ABDec 13, 2024
K240778 · Vivo 1, Vivo 2
- Smd Manufacturing, LLCJul 13, 2023
K231064 · ReddyPort Elbow
- BMC Medical Co., Ltd.Dec 5, 2022
K213169 · BPAP System
- Smd Manufacturing, LLCJan 19, 2018
K171827 · ReddyPort NIV Access Elbow
- Resmed, Ltd.Jan 19, 2017
K161492 · Juno VPAP ST-A