What are FDA adverse event reports for Ventilator, High Frequency?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Ventilator, High Frequency, there are 3,062 total reports including 41 death reports and 559 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Ventilator, High Frequency?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Ventilator, High Frequency

Name: Ventilator, High Frequency - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

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

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

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

#386 of 1000 · 3,062 reports · 1992–2026

BOOK 3,062 reports
RANK #386 of 1000
DEATH 41 death-typed
INJ 559 injury-typed
MALF 2,408 malfunction
SPAN 1992–2026
PEAK 2016: 394
PHOTO Accelerator

Nearest event-volume peer: Accelerator, Linear, Medical (10 report gap)

Ventilator, High Frequency sits #386 of 1000 among tracked device types with 3,062 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 →

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 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
INJ 18.3% corpus 30.4% · below corpus mean (-12.2 pp)
MALF 78.6% corpus 64.5% · above corpus mean (+14.1 pp)

Lead product-problem code Mechanical Problem is 40% of coded problems · Lead manufacturer VYAIRE MEDICAL accounts for 47% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .

Collector

3,090
Stimulator

3,075
Ventilator (this)

3,062
Accelerator

3,052
Prosthesis

3,051
Saline

3,051

What this shows Ventilator, High Frequency carries 3,062 MAUDE reports, ranked #386 of 1000.

Event Types

Malfunction 2,408 (78.6%)

Injury 559 (18.3%)

Death 41 (1.3%)

Other 34 (1.1%)

20 (0.7%)

Patient Outcomes

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

2,347 (75.8%)

Required Intervention 539 (17.4%)

Other 99 (3.2%)

Death 41 (1.3%)

Life Threatening 28 (0.9%)

R 25 (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%)

Yearly Trend

1992: 1

1993: 2

1994: 2

1995: 1

1996: 53

1997: 128

1998: 107

1999: 110

2000: 77

2001: 67

2002: 92

2003: 70

2004: 58

2005: 33

2006: 52

2007: 35

2008: 58

2009: 35

2010: 35

2011: 47

2012: 47

2013: 34

2014: 29

2015: 195

2016: 394

2017: 140

2018: 88

2019: 88

2020: 154

2021: 224

2022: 220

2023: 186

2024: 110

2025: 73

2026: 17

Top Manufacturers

VYAIRE MEDICAL 694

CAREFUSION 574

CAREFUSION, INC 218

Event Locations

1,329 (43.4%)

I 1,126 (36.8%)

HOSPITAL 423 (13.8%)

INVALID DATA 116 (3.8%)

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 similar MAUDE profiles

Two openFDA-derived peer sets for Ventilator, High Frequency, 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 (3,062 here).

Accelerator, Linear, Medical 3,052 Prosthesis, Esophageal 3,051 Saline, Vascular Access Flush 3,051 Stimulator 3,075

Similar death-typed counts

Nearest other device types by death-typed report count (41 here), distinct from the volume row.

Bed, Flotation Therapy, Powered 41 Filter, Bacterial, Breathing-Circuit 41 Hysteroscope 41 Source, Brachytherapy, Radionuclide 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.

Ventilator, High Frequency

Event-type mix vs corpus