2026 data FDA MAUDE openFDA FDA Class II

Ventilator, Continuous, Facility Use

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).

FDA MAUDE casebook

openFDA event book Ventilator, Continuous, Facility Use HEAVY-BOOK · MAUDE

#20 of 1000 · 212,024 reports · 1991–2026

  • BOOK 212,024 reports
  • RANK #20 of 1000
  • DEATH 2,253 death-typed
  • INJ 14,388 injury-typed
  • MALF 194,497 malfunction
  • SPAN 1991–2026
  • PEAK 2023: 24,928
  • PHOTO Drug Eluting Permanen…

Nearest event-volume peer: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (16,070 report gap)

Ventilator, Continuous, Facility Use sits #20 of 1000 among tracked device types with 212,024 MAUDE reports spanning 1991–2026. 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, Facility Use carries 91.7% MALFUNCTION-coded reports, 26.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 6.8% corpus 30.3% · below corpus mean (-23.5 pp)
  • MALF 91.7% corpus 64.8% · above corpus mean (+26.9 pp)

Lead product-problem code Device Displays Incorrect Message is 12% of coded problems · Lead manufacturer RESPIRONICS, INC. accounts for 25% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Ventilator, Continuous, Facility Use in the event-volume neighbourhood

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

reports

What this shows Ventilator, Continuous, Facility Use carries 212,024 MAUDE reports, ranked #20 of 1000.

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

Event Types

Malfunction 194,497 (91.7%)
Injury 14,388 (6.8%)
Death 2,253 (1.1%)
455 (0.2%)
Other 428 (0.2%)
No answer provided 3 (0.0%)

Patient Outcomes

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

188,167 (89.0%)
Required Intervention 12,777 (6.0%)
Other 4,889 (2.3%)
Death 2,233 (1.1%)
Life Threatening 1,563 (0.7%)
R 643 (0.3%)
Hospitalization 448 (0.2%)
L 188 (0.1%)
O 169 (0.1%)
Disability 108 (0.1%)
S 92 (0.0%)
H 52 (0.0%)
D 30 (0.0%)
Congenital Anomaly 20 (0.0%)
Invalid Data 5 (0.0%)

Top Product Problems

Device Displays Incorrect Message 19,239
Mechanical Problem 15,775
Output Problem 12,841
Device Operates Differently Than Expected 11,826
No Display/Image 11,004
Circuit Failure 9,568
Battery Problem 9,519
Device Inoperable 9,082
Electrical /Electronic Property Problem 7,693
Failure to Cycle 7,633
Failure to Calibrate 7,025
Failure to Recalibrate 6,120
Failure to Power Up 6,047
Failure to Run on Battery 5,483
Failure to Charge 5,378
Failure of Device to Self-Test 4,507
Defective Component 4,389
Device Alarm System 3,769
Insufficient Flow or Under Infusion 3,626
Display or Visual Feedback Problem 3,278

Yearly Trend

91
1991: 1
92
1992: 68
93
1993: 63
94
1994: 135
95
1995: 133
96
1996: 593
97
1997: 1,262
98
1998: 1,043
99
1999: 923
00
2000: 692
01
2001: 801
02
2002: 1,011
03
2003: 1,273
04
2004: 1,301
05
2005: 1,439
06
2006: 1,423
07
2007: 1,530
08
2008: 1,933
09
2009: 1,766
10
2010: 1,799
11
2011: 1,877
12
2012: 5,509
13
2013: 7,921
14
2014: 7,600
15
2015: 11,876
16
2016: 16,056
17
2017: 14,451
18
2018: 9,849
19
2019: 9,100
20
2020: 11,096
21
2021: 13,322
22
2022: 15,974
23
2023: 24,928
24
2024: 20,336
25
2025: 14,199
26
2026: 8,741

Reports fell to 14,199 in 2025, down from an average of 22,632 in the two years before.

Related Entities for Ventilator, Continuous, Facility Use

Event Locations

120,872 (57.0%)
I 74,783 (35.3%)
HOSPITAL 9,392 (4.4%)
OTHER 2,710 (1.3%)
UNKNOWN 1,606 (0.8%)
NO INFORMATION 910 (0.4%)
NOT APPLICABLE 649 (0.3%)
HOME 559 (0.3%)
INVALID DATA 378 (0.2%)
NURSING HOME 128 (0.1%)
OUTPATIENT TREATMENT FACILITY 24 (0.0%)
AMBULATORY SURGICAL FACILITY 6 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
AMBULATORY SURGICAL CENTER 1 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)
PUBLIC VENUE 1 (0.0%)
STREET 1 (0.0%)

Compare RESPIRONICS, INC. vs MAQUET CRITICAL CARE AB →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ventilator, Continuous, Facility Use: 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 (212,024 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2,253 here), distinct from the volume row.

Disclaimer: MAUDE figures for Ventilator, Continuous, Facility Use 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, Facility Use; 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.