2026 data FDA MAUDE openFDA

Ventilator, Continuous, Minimal Ventilatory Support, 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 MID-BOOK · MAUDE

#73 of 1000 · 45,754 reports · 2000–2026

  • BOOK 45,754 reports
  • RANK #73 of 1000
  • DEATH 239 death-typed
  • INJ 507 injury-typed
  • MALF 44,958 malfunction
  • SPAN 2000–2026
  • PEAK 2019: 9,350
  • PHOTO Tubes

Nearest event-volume peer: Tubes, Vials, Systems, Serum Separators, Blood Collection (468 report gap)

Ventilator, Continuous, Minimal Ventilatory Support, Facility Use sits #73 of 1000 among tracked device types with 45,754 MAUDE reports spanning 2000–2026. 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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 1.1% corpus 30.4% · below corpus mean (-29.3 pp)
  • MALF 98.3% corpus 64.5% · above corpus mean (+33.8 pp)

Lead product-problem code Inadequate User Interface is 13% of coded problems · Lead manufacturer RESPIRONICS CALIFORNIA, INC accounts for 50% of manufacturer-tagged reports · Top event location I is 52% of location-tagged rows .

Ventilator in the event-volume neighbourhood

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

reports

What this shows Ventilator, Continuous, Minimal Ventilatory Support, Facility Use carries 45,754 MAUDE reports, ranked #73 of 1000.

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

Event Types

Malfunction 44,958 (98.3%)
Injury 507 (1.1%)
Death 239 (0.5%)
Other 37 (0.1%)
13 (0.0%)

Patient Outcomes

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

44,789 (98.0%)
Required Intervention 288 (0.6%)
Death 227 (0.5%)
Other 219 (0.5%)
Life Threatening 72 (0.2%)
Hospitalization 31 (0.1%)
R 28 (0.1%)
L 12 (0.0%)
O 9 (0.0%)
D 6 (0.0%)
Disability 6 (0.0%)
H 4 (0.0%)
S 3 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Inadequate User Interface 4,175
Device Displays Incorrect Message 3,335
Electrical /Electronic Property Problem 2,227
Device Alarm System 2,061
Defective Component 1,974
Battery Problem 1,665
Device Sensing Problem 1,566
Incorrect, Inadequate or Imprecise Result or Readings 1,461
Therapeutic or Diagnostic Output Failure 1,448
Failure to Power Up 1,402
Defective Device 1,278
Device Operates Differently Than Expected 1,229
No Display/Image 1,156
Unexpected Shutdown 1,036
Power Problem 969
Circuit Failure 919
Failure to Sense 831
Output Problem 806
Device Inoperable 799
Mechanical Problem 712

Yearly Trend

00
2000: 2
01
2001: 4
02
2002: 3
04
2004: 6
05
2005: 7
06
2006: 7
07
2007: 59
08
2008: 76
09
2009: 29
10
2010: 63
11
2011: 170
12
2012: 257
13
2013: 322
14
2014: 887
15
2015: 1,657
16
2016: 2,516
17
2017: 2,878
18
2018: 2,203
19
2019: 9,350
20
2020: 4,170
21
2021: 3,790
22
2022: 3,277
23
2023: 4,565
24
2024: 4,808
25
2025: 3,587
26
2026: 1,061

Related Entities for Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

Event Locations

I 23,871 (52.2%)
21,653 (47.3%)
HOSPITAL 141 (0.3%)
NO INFORMATION 72 (0.2%)
OTHER 12 (0.0%)
HOME 3 (0.0%)
INVALID DATA 1 (0.0%)
NURSING HOME 1 (0.0%)

Compare RESPIRONICS CALIFORNIA, INC vs RESPIRONICS, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Ventilator, 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 (45,754 here).

Similar death-typed counts

Nearest other device types by death-typed report count (239 here), distinct from the volume row.

Disclaimer: MAUDE figures for Ventilator 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; 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.