# K023366: Datex-Ohmeda 7900 Ventilator Enhancements

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Oct 7, 2003 after 364 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930017 (1994). 4 ancestors in all.
134 later devices descend from it; 7 cite it directly.
44 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960964: Ohmeda 7900 Anesthesia Ventilator, Ohmeda Medical (1996) Summary page 1.
- K973896: Ohmeda Excel 3000 Anesthesia System, Ohmeda Medical (1998) Summary page 1.
- K973985: AS/3 Anaesthesia Delivery Unit (as/3 Adu), Datex-Engstrom, Inc. (1998) Summary page 1.
- K930017: PB 7200 Series Ventilatory System W/Keyboard, Puritan Bennett Corp. (1994) Summary page 1.

## Most influential descendants
- K041775: GE Datex-Ohmeda Engstrom Carestation (2004), 107 descendants of its own
- K051767: LTV 1000 Ventilator (2005), 57 descendants of its own
- K051895: GE Datex-Ohmeda Engstrom Carestation (2005), 49 descendants of its own
- K060862: GE Datex-Ohmeda Engstrom Carestation (2006), 48 descendants of its own
- K062710: GE Datex-Ohmeda Engstrom Carestation (2006), 47 descendants of its own

## Recalls of this device
- Jul 19, 2019 · Class II · Z-0115-2020: Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opp
- Dec 15, 2015 · Class II · Z-0678-2016: The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unr
- Apr 10, 2012 · Class I · Z-1787-2012: GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential fo

## Indications for use
This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda AestivdS Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered tot he patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Jntermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation. (optional). This device is to be used only by trained and qualified medical professionals.

Source page: https://510kreport.com/device/K023366
Methodology: https://510kreport.com/methodology