Gas Control Unit, Cardiopulmonary Bypass
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.4300 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Gas Control Unit, Cardiopulmonary Bypass LIGHT-BOOK · MAUDE
#750 of 1000 · 767 reports · 2002–2026
- BOOK 767 reports
- RANK #750 of 1000
- DEATH 3 death-typed
- INJ 8 injury-typed
- MALF 714 malfunction
- SPAN 2002–2026
- PEAK 2025: 128
- PHOTO Surgeon'S Gloves
Nearest event-volume peer: Surgeon'S Gloves (3 report gap)
Gas Control Unit, Cardiopulmonary Bypass sits #750 of 1000 among tracked device types with 767 MAUDE reports spanning 2002–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Injury-coded reports sit below the device-type norm
Gas Control Unit, Cardiopulmonary Bypass carries 1.0% INJURY-coded reports, 29.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
- INJ 1.0% corpus 30.3% · below corpus mean (-29.2 pp)
- MALF 93.1% corpus 64.8% · above corpus mean (+28.3 pp)
Lead product-problem code Gas Output Problem is 49% of coded problems · Lead manufacturer LIVANOVA DEUTSCHLAND accounts for 100% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .
Gas Control Unit, Cardiopulmonary Bypass in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Electrosurgic…
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
772 reports
- Surgeon'S Glo…
Surgeon'S Gloves
770 reports
- Surgical Devi…
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
770 reports
- Gas Control U… (this)
Gas Control Unit, Cardiopulmonary Bypass
767 reports
- Culture Media
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
762 reports
- Table
Table, Radiographic, Tilting
762 reports
What this shows Gas Control Unit, Cardiopulmonary Bypass carries 767 MAUDE reports, ranked #750 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 128 in 2025, up from an average of 74 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Gas Control Unit, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Gas Control Unit, Cardiopulmonary Bypass: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (767 here).
Similar death-typed counts
Nearest other device types by death-typed report count (3 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Gas Control Unit, Cardiopulmonary Bypass are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Gas Control Unit, Cardiopulmonary Bypass; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.