Evolution 3e Ventilator
The eVolution 3e ventilator provides continuous or intermittent mechanical breathing support through invasive or noninvasive interfaces. It is intended for pediatric and adult patients…
The eVolution 3e ventilator provides continuous or intermittent mechanical breathing support through invasive or noninvasive interfaces. It is intended for pediatric and adult patients weighing at least 5 kg who need pressure-based or volume-based ventilation.
The system is electronically controlled and uses dual valves, three hot-wire flow sensors and an electrically controlled exhalation valve. The listed turbine configuration has an internal blower supplying the breathing gas flow.
Listed Item
eVolution 3e Ventilator System
Gas Source and Controls
The wider family also offers a configuration that uses an external compressed-air source. A color touchscreen, keys and a control dial provide access to operating settings and monitoring displays. The ventilator is intended for trained healthcare professionals in hospital and related acute or long-term care settings.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Event Medical, Ltd., United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Manufacturer |
| 510(k) | K113743 |
| Record published | 2022-08-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| eVolution 3e Ventilator- Turbine Essential | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130178 | 2013-10-29 |
| K113743 | 2012-12-18 |
| K072590 | 2008-01-04 |
| K051550 | 2005-07-12 |
| K030341 | 2004-01-16 |
| K021112 | 2002-11-22 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-10-13 | Class I | Component design/selection | A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. | 6441 units total (251 units in US) | 2017-06-22 |
| 2005-08-12 | Not classified | Other | Firm received reports of combustion within the blender system of the Inspiration Ventilator. | 1,602 units | 2012-02-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.