Generator, Pulsatile Flow, 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 III (highest risk, premarket approval required), regulated under 21 CFR §870.4320 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Generator LIGHT-BOOK · MAUDE
#948 of 1000 · 428 reports · 2007–2011
- BOOK 428 reports
- RANK #948 of 1000
- DEATH 0 death-typed
- INJ 0 injury-typed
- MALF 428 malfunction
- SPAN 2007–2011
- PEAK 2011: 236
- PHOTO Forceps
Nearest event-volume peer: Forceps, Biopsy, Electric (1 report gap)
Generator, Pulsatile Flow, Cardiopulmonary Bypass sits #948 of 1000 among tracked device types with 428 MAUDE reports spanning 2007–2011. 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 →
Malfunction reports run above the device-type norm
Generator carries 100.0% MALFUNCTION-coded reports, 35.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 0.0% corpus 30.3% · below corpus mean (-30.3 pp)
- MALF 100.0% corpus 64.8% · above corpus mean (+35.2 pp)
Lead product-problem code Device Operates Differently Than Expected is 22% of coded problems · Lead manufacturer TERUMO CARDIOVASCULAR SYSTEMS CORP. accounts for 80% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .
Generator in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Platelet And…
Platelet And Plasma Separator For Bone Graft Handling
432 reports
- Stand
Stand, Infusion
432 reports
- System
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
431 reports
- Forceps
Forceps, Biopsy, Electric
429 reports
- Generator (this)
Generator, Pulsatile Flow, Cardiopulmonary Bypass
428 reports
- Implant
Implant, Endosseous, Orthodontic
425 reports
What this shows Generator, Pulsatile Flow, Cardiopulmonary Bypass carries 428 MAUDE reports, ranked #948 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 189 in 2010, up from an average of 1 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Generator, Pulsatile Flow, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Compare TERUMO CARDIOVASCULAR SYSTEMS CORP. vs TERUMO CARDIOVASCULAR SYSTEMS CORP →
Nationwide devices with a comparable report-volume footprint
Generator carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (428 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Generator 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 Generator; 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.