PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Ventilator, Continuous, Non-Life-Supporting

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 §868.5895 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Ventilator, Continuous, Non-Life-Supporting MID-BOOK · MAUDE

#205 of 1000 · 11,195 reports · 1997–2026

  • BOOK 11,195 reports
  • RANK #205 of 1000
  • DEATH 392 death-typed
  • INJ 1,194 injury-typed
  • MALF 9,588 malfunction
  • SPAN 1997–2026
  • PEAK 2026: 3,183
  • PHOTO Recorder

Nearest event-volume peer: Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (19 report gap)

Ventilator, Continuous, Non-Life-Supporting sits #205 of 1000 among tracked device types with 11,195 MAUDE reports spanning 1997–2026. 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, Continuous, Non-Life-Supporting carries 85.6% MALFUNCTION-coded reports, 20.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.5% corpus 1.5% · above corpus mean (+2.0 pp)
  • INJ 10.7% corpus 30.3% · below corpus mean (-19.6 pp)
  • MALF 85.6% corpus 64.8% · above corpus mean (+20.8 pp)

Lead product-problem code Degraded is 73% of coded problems · Lead manufacturer RESPIRONICS, INC. accounts for 89% of manufacturer-tagged reports · Top event location is 95% of location-tagged rows .

Ventilator, Continuous, Non-Life-Supporting in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Ventilator, Continuous, Non-Life-Supporting carries 11,195 MAUDE reports, ranked #205 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 9,588 (85.6%)
Injury 1,194 (10.7%)
Death 392 (3.5%)
Other 20 (0.2%)
1 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

9,027 (81.4%)
Other 1,118 (10.1%)
Death 396 (3.6%)
Required Intervention 113 (1.0%)
Hospitalization 85 (0.8%)
Life Threatening 70 (0.6%)
R 65 (0.6%)
Disability 48 (0.4%)
L 41 (0.4%)
H 38 (0.3%)
O 32 (0.3%)
S 25 (0.2%)
D 22 (0.2%)
Congenital Anomaly 7 (0.1%)

Top Product Problems

Degraded 8,819
Electrical /Electronic Property Problem 1,051
Circuit Failure 664
Contamination 394
Adverse Event Without Identified Device or Use Problem 292
Corroded 235
Device Displays Incorrect Message 69
Unexpected Shutdown 69
Thermal Decomposition of Device 63
Overheating of Device 61
Failure to Power Up 53
Device Alarm System 50
Nonstandard Device 50
Battery Problem 43
Insufficient Device Problem Information 38
Power Problem 31
Pressure Problem 30
Device Sensing Problem 28
Output Problem 26
Device Emits Odor 25

Yearly Trend

97
1997: 2
98
1998: 1
99
1999: 1
01
2001: 1
02
2002: 1
03
2003: 1
04
2004: 5
05
2005: 3
06
2006: 2
07
2007: 9
08
2008: 7
09
2009: 8
10
2010: 9
11
2011: 9
12
2012: 12
13
2013: 18
14
2014: 5
15
2015: 50
16
2016: 16
17
2017: 20
18
2018: 22
19
2019: 275
20
2020: 64
21
2021: 256
22
2022: 2,514
23
2023: 1,320
24
2024: 1,571
25
2025: 1,810
26
2026: 3,183

Reports in 2025 (1,810) held close to the prior two-year average of 1,446.

Related Entities for Ventilator, Continuous, Non-Life-Supporting

Top Manufacturers

RESPIRONICS, INC. 9,669
RESPIRONICS CALIFORNIA, INC 375
RESPIRONICS, INC 339
RESPIRONICS INC 180
Respironics, Inc. 136
RESPIRONICS,INC 95
RESPIRONICS INC. 73
RESPIRONICS CALIFORNIA, LLC 35

Event Locations

10,669 (95.3%)
I 472 (4.2%)
NO INFORMATION 33 (0.3%)
HOSPITAL 13 (0.1%)
NOT APPLICABLE 3 (0.0%)
HOME 2 (0.0%)
NURSING HOME 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare RESPIRONICS, INC. vs RESPIRONICS CALIFORNIA, INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ventilator, Continuous, Non-Life-Supporting: 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 (11,195 here).

Recorder, Event, Implantable Cardiac, 11,214 Compressor, Cardiac, External 11,220 Dermal Cooling Pack/Vacuum/Massager 11,387 Catheter 11,392

Similar death-typed counts

Nearest other device types by death-typed report count (392 here), distinct from the volume row.

Prosthesis, Hip, Semi-Constrained 387 Mesh 376 Prosthesis 375 Temporary Non-Roller Type Right Heart Suppo… 410

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Ventilator, Continuous, Non-Life-Supporting 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, Continuous, Non-Life-Supporting; 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.