Console, Heart-Lung Machine, 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 MAUDE casebook
openFDA event book Console MID-BOOK · MAUDE
#152 of 1000 · 16,733 reports · 1992–2026
- BOOK 16,733 reports
- RANK #152 of 1000
- DEATH 256 death-typed
- INJ 441 injury-typed
- MALF 15,086 malfunction
- SPAN 1992–2026
- PEAK 2012: 1,626
- PHOTO Humidifier
Nearest event-volume peer: Humidifier, Respiratory Gas, (Direct Patient Interface) (47 report gap)
Console, Heart-Lung Machine, Cardiopulmonary Bypass sits #152 of 1000 among tracked device types with 16,733 MAUDE reports spanning 1992–2026. 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 →
Event-type mix vs corpus
Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.
- DEATH 1.5% corpus 1.5% · near corpus mean (+0.0 pp)
- INJ 2.6% corpus 30.4% · below corpus mean (-27.8 pp)
- MALF 90.2% corpus 64.5% · above corpus mean (+25.7 pp)
Lead product-problem code Output Problem is 14% of coded problems · Lead manufacturer TERUMO CARDIOVASCULAR SYSTEMS CORP. accounts for 42% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .
Console in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Console (this)
Console, Heart-Lung Machine, Cardiopulmonary Bypass
16,733 reports
- Humidifier
Humidifier, Respiratory Gas, (Direct Patient Interface)
16,686 reports
- Dc-Defibrilla…
Dc-Defibrillator, Low-Energy, (Including Paddles)
16,560 reports
- Unit
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
16,529 reports
- Drills
Drills, Burrs, Trephines & Accessories (Simple, Powered)
16,522 reports
- Aligner
Aligner, Sequential
16,486 reports
What this shows Console, Heart-Lung Machine, Cardiopulmonary Bypass carries 16,733 MAUDE reports, ranked #152 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
Related Entities for Console, Heart-Lung Machine, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Compare TERUMO CARDIOVASCULAR SYSTEMS CORP. vs TERUMO CARDIOVASCULAR SYSTEMS CORPORATION →
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Console, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (16,733 here).
Similar death-typed counts
Nearest other device types by death-typed report count (256 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Console 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 Console; 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.