Ventilator, Non-Continuous (Respirator)
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 §868.5905 (Anesthesiology panel).
FDA MAUDE casebook
openFDA event book Ventilator, Non-Continuous HEAVY-BOOK · MAUDE
#15 of 1000 · 300,898 reports · 1993–2026
- BOOK 300,898 reports
- RANK #15 of 1000
- DEATH 4,569 death-typed
- INJ 53,622 injury-typed
- MALF 242,512 malfunction
- SPAN 1993–2026
- PEAK 2022: 90,768
- PHOTO Set
Nearest event-volume peer: Set, Administration, Intravascular (9,079 report gap)
Ventilator, Non-Continuous (Respirator) sits #15 of 1000 among tracked device types with 300,898 MAUDE reports spanning 1993–2026. 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 →
Malfunction reports run above the device-type norm
Ventilator, Non-Continuous carries 80.6% MALFUNCTION-coded reports, 15.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.5% corpus 1.5% · near corpus mean (+0.0 pp)
- INJ 17.8% corpus 30.3% · below corpus mean (-12.5 pp)
- MALF 80.6% corpus 64.8% · above corpus mean (+15.8 pp)
Lead product-problem code Degraded is 91% of coded problems · Lead manufacturer RESPIRONICS, INC. accounts for 90% of manufacturer-tagged reports · Top event location is 99% of location-tagged rows .
Ventilator, Non-Continuous in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Permanent Pac…
Permanent Pacemaker Electrode
325,343 reports
- Sensor
Sensor, Glucose, Invasive, Non-Adjunctive
324,715 reports
- Set
Set, Administration, Intravascular
309,977 reports
- Ventilator (this)
Ventilator, Non-Continuous (Respirator)
300,898 reports
- Sensor
Sensor, Glucose, Invasive
281,941 reports
- Automated Ext…
Automated External Defibrillators (Non-Wearable)
268,697 reports
What this shows Ventilator, Non-Continuous (Respirator) carries 300,898 MAUDE reports, ranked #15 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 in 2025 (60,713) held close to the prior two-year average of 48,125.
Related Entities for Ventilator, Non-Continuous (Respirator)
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Ventilator, Non-Continuous: 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 (300,898 here).
Similar death-typed counts
Nearest other device types by death-typed report count (4,569 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Ventilator, Non-Continuous 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 Ventilator, Non-Continuous; 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.