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2026 data FDA MAUDE openFDA FDA Class III

Ventilator, High Frequency

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

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FDA MAUDE casebook

openFDA event book Ventilator, High Frequency LIGHT-BOOK · MAUDE

#399 of 1000 · 3,097 reports · 1992–2026

  • BOOK 3,097 reports
  • RANK #399 of 1000
  • DEATH 42 death-typed
  • INJ 560 injury-typed
  • MALF 2,441 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 394
  • PHOTO Joint

Nearest event-volume peer: Joint, Temporomandibular, Implant (1 report gap)

Ventilator, High Frequency sits #399 of 1000 among tracked device types with 3,097 MAUDE reports spanning 1992–2026. 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, High Frequency carries 78.8% MALFUNCTION-coded reports, 14.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 18.1% corpus 30.3% · below corpus mean (-12.2 pp)
  • MALF 78.8% corpus 64.8% · above corpus mean (+14.0 pp)

Lead product-problem code Mechanical Problem is 23% of coded problems · Lead manufacturer VYAIRE MEDICAL accounts for 47% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Ventilator, High Frequency in the event-volume neighbourhood

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

reports

What this shows Ventilator, High Frequency carries 3,097 MAUDE reports, ranked #399 of 1000.

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

Event Types

Malfunction 2,441 (78.8%)
Injury 560 (18.1%)
Death 42 (1.4%)
Other 34 (1.1%)
20 (0.6%)

Patient Outcomes

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

2,378 (76.0%)
Required Intervention 539 (17.2%)
Other 100 (3.2%)
Death 42 (1.3%)
Life Threatening 28 (0.9%)
R 26 (0.8%)
Hospitalization 4 (0.1%)
L 3 (0.1%)
S 3 (0.1%)
Disability 3 (0.1%)
O 2 (0.1%)
Invalid Data 1 (0.0%)

Top Product Problems

Mechanical Problem 618
Device Operates Differently Than Expected 429
Replace 347
Failure to Cycle 186
Pressure Problem 129
No Audible Alarm 107
Device Inoperable 99
Decrease in Pressure 98
Device Stops Intermittently 89
Device Alarm System 81
Loss of Power 78
Device Issue 71
Other (for use when an appropriate device code cannot be identified) 68
Device Displays Incorrect Message 59
Overheating of Device 58
Noise 52
Leak/Splash 44
Device Emits Odor 42
Alarm, audible 40
Failure to Power Up 38

Yearly Trend

92
1992: 1
93
1993: 2
94
1994: 2
95
1995: 1
96
1996: 53
97
1997: 128
98
1998: 107
99
1999: 110
00
2000: 77
01
2001: 67
02
2002: 92
03
2003: 70
04
2004: 58
05
2005: 33
06
2006: 52
07
2007: 35
08
2008: 58
09
2009: 35
10
2010: 35
11
2011: 47
12
2012: 47
13
2013: 34
14
2014: 29
15
2015: 195
16
2016: 394
17
2017: 140
18
2018: 88
19
2019: 88
20
2020: 154
21
2021: 224
22
2022: 220
23
2023: 186
24
2024: 110
25
2025: 73
26
2026: 52

Reports fell to 73 in 2025, down from an average of 148 in the two years before.

Related Entities for Ventilator, High Frequency

Top Manufacturers

VYAIRE MEDICAL 694
CAREFUSION 574
CAREFUSION, INC 218

Event Locations

1,363 (44.0%)
I 1,126 (36.4%)
HOSPITAL 424 (13.7%)
INVALID DATA 116 (3.7%)
OTHER 46 (1.5%)
NO INFORMATION 14 (0.5%)
NOT APPLICABLE 3 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)
UNKNOWN 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare VYAIRE MEDICAL vs CAREFUSION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ventilator, High Frequency: 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 (3,097 here).

Joint, Temporomandibular, Implant 3,096 Prosthesis, Esophageal 3,094 Test, Hepatitis B 3,089 Monitor, Cardiac 3,110

Similar death-typed counts

Nearest other device types by death-typed report count (42 here), distinct from the volume row.

Bed, Flotation Therapy, Powered 42 Catheters, Suction, Tracheobronchial 42 Bath, Hydro-Massage 43 Filter, Bacterial, Breathing-Circuit 41

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

Disclaimer: MAUDE figures for Ventilator, High Frequency 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, High Frequency; 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.