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2026 data FDA MAUDE openFDA FDA Class II

Apparatus, Nitric Oxide Delivery

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 §868.5165 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Apparatus, Nitric Oxide Delivery LIGHT-BOOK · MAUDE

#496 of 1000 · 2,049 reports · 1998–2026

  • BOOK 2,049 reports
  • RANK #496 of 1000
  • DEATH 30 death-typed
  • INJ 139 injury-typed
  • MALF 1,833 malfunction
  • SPAN 1998–2026
  • PEAK 2021: 221
  • PHOTO Filler

Nearest event-volume peer: Filler, Bone Void, Calcium Compound (7 report gap)

Apparatus, Nitric Oxide Delivery sits #496 of 1000 among tracked device types with 2,049 MAUDE reports spanning 1998–2026. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Apparatus, Nitric Oxide Delivery carries 89.5% MALFUNCTION-coded reports, 24.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.5% corpus 1.5% · near corpus mean (-0.0 pp)
  • INJ 6.8% corpus 30.3% · below corpus mean (-23.5 pp)
  • MALF 89.5% corpus 64.8% · above corpus mean (+24.6 pp)

Lead product-problem code Failure to Deliver is 17% of coded problems · Top event location is 50% of location-tagged rows .

Apparatus, Nitric Oxide Delivery in the event-volume neighbourhood

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

reports

What this shows Apparatus, Nitric Oxide Delivery carries 2,049 MAUDE reports, ranked #496 of 1000.

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

Event Types

Malfunction 1,833 (89.5%)
Injury 139 (6.8%)
Death 30 (1.5%)
25 (1.2%)
Other 22 (1.1%)

Patient Outcomes

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

1,787 (85.5%)
Other 100 (4.8%)
Required Intervention 67 (3.2%)
Life Threatening 40 (1.9%)
Death 36 (1.7%)
R 20 (1.0%)
O 15 (0.7%)
L 10 (0.5%)
Hospitalization 9 (0.4%)
D 2 (0.1%)
H 1 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Failure to Deliver 377
Device Displays Incorrect Message 280
High Readings 230
Failure to Recalibrate 227
Intermittent Communication Failure 219
Inaccurate Delivery 187
Device Operates Differently Than Expected 124
No Display/Image 77
Calibration Problem 70
Gas Output Problem 60
Failure to Calibrate 56
Device Alarm System 54
Excess Flow or Over-Infusion 50
Gas/Air Leak 47
Device Inoperable 40
Break 34
Therapeutic or Diagnostic Output Failure 34
Loose or Intermittent Connection 33
Nonstandard Device 28
Device Sensing Problem 27

Yearly Trend

98
1998: 2
01
2001: 2
02
2002: 3
03
2003: 1
04
2004: 4
05
2005: 1
06
2006: 5
07
2007: 3
08
2008: 9
09
2009: 10
10
2010: 155
11
2011: 55
12
2012: 24
13
2013: 32
14
2014: 79
15
2015: 156
16
2016: 94
17
2017: 106
18
2018: 138
19
2019: 144
20
2020: 199
21
2021: 221
22
2022: 115
23
2023: 99
24
2024: 138
25
2025: 158
26
2026: 96

Reports in 2025 (158) held close to the prior two-year average of 119.

Related Entities for Apparatus, Nitric Oxide Delivery

Event Locations

1,028 (50.2%)
I 883 (43.1%)
HOSPITAL 113 (5.5%)
NO INFORMATION 19 (0.9%)
OTHER 4 (0.2%)
HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Apparatus, Nitric Oxide Delivery: 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 (2,049 here).

Filler, Bone Void, Calcium Compound 2,056 Ligator, Hemorrhoidal 2,058 Continuous Glucose Monitor Retrospective Da… 2,060 Prosthesis 2,066

Similar death-typed counts

Nearest other device types by death-typed report count (30 here), distinct from the volume row.

Barrier, Absorbable, Adhesion 30 Bed, Patient Rotation, Powered 30 Cannula, Nasal, Oxygen 30 Carboxymethylcellulose Sodium Or Polyvinyl… 30

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

Disclaimer: MAUDE figures for Apparatus, Nitric Oxide Delivery 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 Apparatus, Nitric Oxide Delivery; 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.