Ventilator, Continuous, Non-Life-Supporting
FDA adverse event reports and recall history for ventilator, continuous, non-life-supporting (product code MNS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 10,800
- Deaths
- 393
- Injuries
- 1,193
- Malfunctions
- 9,193
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-07-02Open, ClassifiedDevice Design
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.
- 2025-07-02Open, ClassifiedDevice Design
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
This device does not indicate for use in patients with respiratory failure.
- 2024-05-24Open, ClassifiedDevice Design
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.
- 2024-05-24Open, ClassifiedDevice Design
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
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.
- 2024-05-23Open, ClassifiedDevice Design
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
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.
- 2022-09-09Open, ClassifiedProcess control
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.
- 2022-09-09Open, ClassifiedProcess control
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.
- 2022-09-09Open, ClassifiedProcess control
Philips BiPAP V30 Auto, 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.
- 2022-09-09Open, ClassifiedProcess control
Philips OmniLab Advanced+, 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.
- 2022-09-09Open, ClassifiedProcess control
Philips OmniLab Advanced+ Intl (Flow Gen), 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.
Monitor ventilator, continuous, non-life-supporting automatically
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