DTXClass IILife-sustaining
Gas Control Unit, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4300
MDR events767All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances10All time
Recent MDR events
767 adverse event reports on file
- Electronic Gas BlenderJul 30, 2026MalfunctionLivanova Deutschland Gmbh9611109-2026-90348
- QuantumJul 29, 2026MalfunctionSpectrum Medical Ltd3006073153-2026-00173
- EGBJul 29, 2026MalfunctionLivanova Deutschland9611109-2026-90340
- Electronic Gas BlenderJul 29, 2026MalfunctionLivanova Deutschland Gmbh9611109-2026-90343
- EGBJul 28, 2026MalfunctionLivanova Deutschland9611109-2026-90332
- S5 COMPONENT GAS BLENDERJul 27, 2026MalfunctionLivanova Deutschland9611109-2026-90330
- SECHRIST INDUSTRIES INC.Jul 22, 2026MalfunctionSechrist Industries Inc.2020267-2026-00009
- QUANTUM VENTILATION MODULEJul 21, 2026InjurySpectrum Medical Ltd3006073153-2026-00172
- ELECTRONIC GAS BLENDERJul 15, 2026MalfunctionLivanova Deutschland9611109-2026-90311
- QUANTUMJul 13, 2026MalfunctionSpectrum Medical Ltd3006073153-2026-00169
Event type breakdown
Malfunction714
Other27
Unspecified15
Injury8
Death3
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
10 clearances for this product code
- Spectrum Medical , Ltd.May 4, 2021
K210669 · Quantum Mini Ventilation Module
- Spectrum Medical , Ltd.Oct 16, 2020
K202733 · Quantum Ventilation Module
- Spectrum Medical , Ltd.Oct 18, 2018
K181942 · Quantum Ventilation Module
- Sorin Group Deutschland GmbHDec 9, 2010
K101046 · STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
- Sechrist Industries, Inc.Jan 17, 2003
K023745 · SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
- Coeur Laboratories, Inc.Mar 28, 1997
K965214 · COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
- 3M Health Care, SarnsDec 11, 1986
K863902 · MODIFIED SARNS MEMBRANE OXYGENATOR
- Gambro, Inc.Oct 18, 1982
K822820 · GAS-FLOW METER GFL 10