Servo Ventilator 300A

• • Terminated Z-0588-2010 FDA Unclassified (pre-2012) ·initiated 17 Nov 2009

  Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.

• • Terminated Z-1252-2009 FDA Unclassified (pre-2012) ·initiated 23 Mar 2009

  The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.

• • Terminated Z-0872-2009 FDA Unclassified (pre-2012) ·initiated 19 Dec 2008

  SERVO Ventilator 300A could cause hypoventilation if the use of the PC or PRVC mode with the Automode function set to "On" in Neonatal and Pediatric patient ranges with small tidal volumes and short set inspiratory rise time.

• • Terminated Z-0571-05 FDA Unclassified (pre-2012) ·initiated 3 Jan 2005

  Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.

510(k) Number

K970839 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

ST

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See all devices from Siemens Elema AB →

• Is the Servo Ventilator 300A designed for use in home settings or only in facility-based environments like hospitals and clinics?

  The Servo Ventilator 300A is explicitly designed for facility-based respiratory support only, meaning it is intended for use in hospitals, clinics, or other healthcare settings where continuous mechanical ventilation is required. It is not approved or intended for home use.

• How often does the Servo Ventilator 300A require maintenance, and what does that process entail?

  The Servo Ventilator 300A requires periodic maintenance, including scheduled overhauls at 1000-hour and 3000-hour intervals. These overhauls must follow the manufacturer’s technical protocols to ensure proper function and safety. Maintenance is not single-use or disposable—it is a reusable device that demands adherence to service guidelines.

• What power supply requirements does the Servo Ventilator 300A have, and does it support global electrical standards?

  The Servo Ventilator 300A operates on mains power ranging from 100V to 240V, making it compatible with most global electrical standards. However, users must ensure their facility’s power supply matches the device’s voltage and frequency requirements to avoid operational issues.

• Is the Servo Ventilator 300A reusable, or is it intended for single-use in a clinical setting?

  The Servo Ventilator 300A is not a single-use device. It is designed for continuous, reusable use in facility-based settings, provided it undergoes the required maintenance and overhauls as specified by Siemens Elema AB. Reusability is a key feature for long-term clinical deployment.