Model note · Ventilator
Draeger Evita Infinity V500 ventilation unit
The Evita V500 is a Draeger intensive care ventilator for adults, children and neonates. In the US it was cleared in 2010 (K093633) as the ventilation unit of the Infinity Acute Care System Workstation Critical Care, with the Infinity Medical Cockpit C500 as its screen and controls, an optional GS500 air supply unit and an optional PS500 battery unit. It offers volume, pressure and spontaneous modes including APRV, PPS and ATC. Draeger has since listed it as end of sale, with the Evita V800 as its successor.
The model
Maker, model and type.
- Maker
- Draeger Medical AG & Co. KG (Draegerwerk)
- Model
- Evita Infinity V500 ventilation unit (Infinity Acute Care System Workstation Critical Care, SW 2.n)
- Device type
- Ventilator
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA clearance | K093633, 30 March 2010, Infinity Acute Care System Workstation Critical Care (common name intensive care ventilator) | Source |
| Modes | VC-SIMV, VC-AC, VC-CMV, VC-MMV; PC-SIMV, PC-SIMV+, PC-AC, PC-CMV, PC-APRV (option), PC-PSV; Spn-CPAP/VS, Spn-CPAP/PS, Spn-PPS (option); apnea ventilation, ATC, flow trigger | Source |
| Tidal volume | Adults 100 to 3000 mL, pediatric 20 to 300 mL, neonates 2 to 100 mL | Source |
| Rate and flow | Rate 0.5 to 98/min adults and 0.5 to 150/min pediatric and neonates; inspiratory flow 2 to 120 L/min adults and 2 to 30 L/min pediatric and neonates; spontaneous breathing flow up to 180 L/min | Source |
| Pressures and oxygen | Pinsp 1 to 95 mbar; Pmax 2 to 100 mbar; PEEP 0 to 50 mbar; Psupp 0 to 95 mbar; FiO2 21 to 100 Vol%; flow trigger 0.2 to 15 L/min | Source |
| Tube compensation | ATC for endotracheal tubes 5 to 12 mm adults, 2 to 8 mm pediatric, 2 to 5 mm neonates; compensation 0 to 100% | Source |
| Operating environment | 10 to 40 degrees C (PS500 charging may stop above 35 degrees C); 700 to 1060 hPa; 10 to 90% humidity without condensation | Source |
| Power and data | 100 to 240 V, 50/60 Hz; internal battery, optional PS500; MEDIBUS or MEDIBUS.X serial ports up to 38400 baud; nurse call relay | Source |
Recalls
Known FDA recalls.
- Z-0870-20222022-02-14
Cybersecurity improvement for software 2.51.01 and lower.
FDA record - Z-0108-20222021-09-10
With the CO2 option and software 2.51 or lower the ventilator may restart, briefly stopping ventilation and losing PEEP for about 8 seconds.
FDA record - Z-0436-20162015-12-01
PS500 battery run times unexpectedly short because of the charging algorithm.
FDA record - Z-1298-20142014-02-07
PS500 battery capacity did not last as long as expected.
FDA record
Safety
Safety warnings from the record.
- Software 2.51 and lower with the CO2 option could restart the ventilator, with a brief stop of ventilation and loss of PEEP for about 8 seconds (2021 recall). Source
- Software 2.51.01 and lower was not protected against some cybersecurity threats (2022 correction). Source
- Observe the maximum load on the side rails (4 kg within 10 cm; 1 kg within 100 cm for hose holders); overloading can tip the device over. Source
Sources
Where this note comes from.
- FDA 510(k) K093633 summary, Infinity Acute Care System Workstation Critical Care
- Draeger, Instructions for use, Infinity Acute Care System, Evita Infinity V500 SW 2.n (third-party hosted copy)
- openFDA device recall records for the Evita V500
- Draeger product page, Evita Infinity V500
Not covered: The IFU read is a 2012 edition for SW 2.n hosted by a distributor; later software changes settings and alarms. The IFU lists many alarm messages but no numbered error codes, so none are given. Internal battery run time and device weight were not found in the pages read. MAUDE reports under the Evita V500 brand name are very few because most are filed under the Infinity Acute Care System name.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.