2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#20 of 1000 · 205,183 reports · 1991–2026

  • BOOK 205,183 reports
  • RANK #20 of 1000
  • DEATH 2,221 death-typed
  • INJ 14,273 injury-typed
  • MALF 187,805 malfunction
  • SPAN 1991–2026
  • PEAK 2023: 24,928
  • PHOTO Set

Nearest event-volume peer: Set, Administration, Intravascular (2,504 report gap)

Ventilator, Continuous, Facility Use sits #20 of 1000 among tracked device types with 205,183 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 7.0% corpus 30.4% · below corpus mean (-23.5 pp)
  • MALF 91.5% corpus 64.5% · above corpus mean (+27.0 pp)

Lead product-problem code Mechanical Problem is 12% of coded problems · Lead manufacturer RESPIRONICS, INC. accounts for 23% of manufacturer-tagged reports · Top event location is 56% 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 205,183 MAUDE reports, ranked #20 of 1000.

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

Event Types

Malfunction 187,805 (91.5%)
Injury 14,273 (7.0%)
Death 2,221 (1.1%)
455 (0.2%)
Other 426 (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.

183,091 (88.8%)
Required Intervention 12,751 (6.2%)
Other 4,816 (2.3%)
Death 2,202 (1.1%)
Life Threatening 1,530 (0.7%)
R 638 (0.3%)
Hospitalization 440 (0.2%)
L 186 (0.1%)
O 166 (0.1%)
Disability 108 (0.1%)
S 92 (0.0%)
H 50 (0.0%)
D 28 (0.0%)
Congenital Anomaly 20 (0.0%)
Invalid Data 5 (0.0%)
C 1 (0.0%)

Top Product Problems

Mechanical Problem 14,722
Output Problem 12,433
Device Displays Incorrect Message 10,393
Circuit Failure 8,815
Battery Problem 8,241
No Display/Image 7,674
Device Operates Differently Than Expected 7,172
Electrical /Electronic Property Problem 6,293
Failure to Calibrate 5,954
Failure to Recalibrate 5,822
Failure to Run on Battery 5,014
Failure to Charge 4,074
Failure to Power Up 4,071
Defective Component 4,043
Failure of Device to Self-Test 3,949
Device Inoperable 3,697
Insufficient Flow or Under Infusion 3,051
Display or Visual Feedback Problem 2,831
Gas/Air Leak 2,817
Improper Flow or Infusion 2,560

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: 1,900

Related Entities for Ventilator, Continuous, Facility Use

Event Locations

114,089 (55.6%)
I 74,786 (36.4%)
HOSPITAL 9,332 (4.5%)
OTHER 2,709 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Ventilator, Continuous, Facility Use, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (205,183 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2,221 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.