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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#488 of 1000 · 1,985 reports · 1998–2026

  • BOOK 1,985 reports
  • RANK #488 of 1000
  • DEATH 28 death-typed
  • INJ 132 injury-typed
  • MALF 1,778 malfunction
  • SPAN 1998–2026
  • PEAK 2021: 221
  • PHOTO Continuous Glucose Mo…

Nearest event-volume peer: Continuous Glucose Monitor Retrospective Data Analysis Software (7 report gap)

Apparatus, Nitric Oxide Delivery sits #488 of 1000 among tracked device types with 1,985 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 →

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 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 6.6% corpus 30.4% · below corpus mean (-23.8 pp)
  • MALF 89.6% corpus 64.5% · above corpus mean (+25.1 pp)

Lead product-problem code Failure to Deliver is 15% of coded problems · Top event location is 49% 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 1,985 MAUDE reports, ranked #488 of 1000.

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

Event Types

Malfunction 1,778 (89.6%)
Injury 132 (6.6%)
Death 28 (1.4%)
25 (1.3%)
Other 22 (1.1%)

Patient Outcomes

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

1,740 (85.7%)
Other 99 (4.9%)
Required Intervention 62 (3.1%)
Life Threatening 37 (1.8%)
Death 34 (1.7%)
R 19 (0.9%)
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 262
High Readings 224
Failure to Recalibrate 221
Intermittent Communication Failure 215
Device Displays Incorrect Message 190
Inaccurate Delivery 140
Device Operates Differently Than Expected 59
Calibration Problem 49
Excess Flow or Over-Infusion 46
Device Alarm System 42
Failure to Calibrate 41
Gas Output Problem 35
Therapeutic or Diagnostic Output Failure 33
Break 30
Loose or Intermittent Connection 29
Defective Device 19
Device Sensing Problem 19
Device Inoperable 17
Inappropriate or Unexpected Reset 17
Defective Component 16

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: 32

Related Entities for Apparatus, Nitric Oxide Delivery

Event Locations

968 (48.8%)
I 883 (44.5%)
HOSPITAL 109 (5.5%)
NO INFORMATION 19 (1.0%)
OTHER 4 (0.2%)
HOME 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Apparatus, Nitric Oxide Delivery, 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 (1,985 here).

Continuous Glucose Monitor Retrospective Da… 1,978 Pancreatic Stent 1,992 Tourniquet, Pneumatic 1,978 Apparatus 1,975

Similar death-typed counts

Nearest other device types by death-typed report count (28 here), distinct from the volume row.

Catheter 28 Over-The-Counter Automated External Defibri… 28 Pump, Portable, Aspiration 28 Catheter, Urological 29

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.