Monitor, Blood-Gas, On-Line, 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 §870.4330 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Monitor LIGHT-BOOK · MAUDE
#319 of 1000 · 5,034 reports · 1992–2026
- BOOK 5,034 reports
- RANK #319 of 1000
- DEATH 8 death-typed
- INJ 25 injury-typed
- MALF 4,748 malfunction
- SPAN 1992–2026
- PEAK 2011: 2,268
- PHOTO Accessories
Nearest event-volume peer: Accessories, Cleaning, For Endoscope (12 report gap)
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass sits #319 of 1000 among tracked device types with 5,034 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 →
Injury-coded reports sit below the device-type norm
Monitor carries 0.5% INJURY-coded reports, 29.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 0.5% corpus 30.3% · below corpus mean (-29.8 pp)
- MALF 94.3% corpus 64.8% · above corpus mean (+29.5 pp)
Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 17% of coded problems · Lead manufacturer TERUMO CARDIOVASCULAR SYSTEMS CORP. accounts for 69% of manufacturer-tagged reports · Top event location is 74% of location-tagged rows .
Monitor in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Accessories
Accessories, Arthroscopic
5,126 reports
- Stimulator
Stimulator, Nerve
5,083 reports
- Accessories
Accessories, Cleaning, For Endoscope
5,046 reports
- Monitor (this)
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
5,034 reports
- Ophthalmic Fe…
Ophthalmic Femtosecond Laser
5,003 reports
- Tape And Band…
Tape And Bandage, Adhesive
4,983 reports
What this shows Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass carries 5,034 MAUDE reports, ranked #319 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 139 in 2025, up from an average of 57 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Compare TERUMO CARDIOVASCULAR SYSTEMS CORP. vs TERUMO CARDIOVASCULAR SYSTEMS CORPORATION →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Monitor: 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 (5,034 here).
Similar death-typed counts
Nearest other device types by death-typed report count (8 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Monitor 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 Monitor; 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.