2026 data FDA MAUDE openFDA FDA Class II

Continuous, Ventilator, Home 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 Continuous, Ventilator, Home Use LIGHT-BOOK · MAUDE

#267 of 1000 · 6,912 reports · 2006–2026

  • BOOK 6,912 reports
  • RANK #267 of 1000
  • DEATH 92 death-typed
  • INJ 191 injury-typed
  • MALF 6,621 malfunction
  • SPAN 2006–2026
  • PEAK 2023: 1,259
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing (26 report gap)

Continuous, Ventilator, Home Use sits #267 of 1000 among tracked device types with 6,912 MAUDE reports spanning 2006–2026. 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

Continuous, Ventilator, Home Use carries 95.8% MALFUNCTION-coded reports, 31.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 2.8% corpus 30.3% · below corpus mean (-27.5 pp)
  • MALF 95.8% corpus 64.8% · above corpus mean (+31.0 pp)

Lead product-problem code Protective Measures Problem is 29% of coded problems · Lead manufacturer RESMED LTD accounts for 92% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

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

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

reports

What this shows Continuous, Ventilator, Home Use carries 6,912 MAUDE reports, ranked #267 of 1000.

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

Event Types

Malfunction 6,621 (95.8%)
Injury 191 (2.8%)
Death 92 (1.3%)
7 (0.1%)
Other 1 (0.0%)

Patient Outcomes

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

6,366 (93.1%)
Other 182 (2.7%)
Required Intervention 101 (1.5%)
Death 81 (1.2%)
Hospitalization 29 (0.4%)
Life Threatening 23 (0.3%)
H 15 (0.2%)
O 10 (0.1%)
L 9 (0.1%)
R 8 (0.1%)
S 6 (0.1%)
D 5 (0.1%)
Disability 3 (0.0%)

Top Product Problems

Protective Measures Problem 2,280
Failure to Calibrate 1,069
Device Displays Incorrect Message 1,040
Battery Problem 818
Power Problem 424
Inadequate User Interface 390
Failure to Power Up 204
Failure to Charge 198
Charging Problem 182
Electrical /Electronic Property Problem 170
Failure of Device to Self-Test 150
Inappropriate or Unexpected Reset 149
Complete Loss of Power 132
No Display/Image 127
Device Inoperable 114
Unexpected Shutdown 114
Inappropriate Tactile Prompt/Feedback 87
Device Stops Intermittently 81
Device Alarm System 79
Adverse Event Without Identified Device or Use Problem 50

Yearly Trend

06
2006: 2
07
2007: 1
12
2012: 1
13
2013: 5
14
2014: 112
15
2015: 1,217
16
2016: 1,160
17
2017: 175
18
2018: 41
19
2019: 37
20
2020: 67
21
2021: 248
22
2022: 336
23
2023: 1,259
24
2024: 817
25
2025: 935
26
2026: 499

Reports in 2025 (935) held close to the prior two-year average of 1,038.

Related Entities for Continuous, Ventilator, Home Use

Top Manufacturers

Event Locations

4,386 (63.5%)
I 2,374 (34.3%)
HOME 62 (0.9%)
HOSPITAL 56 (0.8%)
NO INFORMATION 23 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 6 (0.1%)
NURSING HOME 2 (0.0%)
OTHER 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare RESMED LTD vs RESMED LTD. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Continuous, Ventilator, Home 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 (6,912 here).

Similar death-typed counts

Nearest other device types by death-typed report count (92 here), distinct from the volume row.

Disclaimer: MAUDE figures for Continuous, Ventilator, Home 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 Continuous, Ventilator, Home 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.