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2026 data FDA MAUDE openFDA

Mask, Oxygen

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 Mask, Oxygen LIGHT-BOOK · MAUDE

#904 of 1000 · 456 reports · 1992–2026

  • BOOK 456 reports
  • RANK #904 of 1000
  • DEATH 9 death-typed
  • INJ 71 injury-typed
  • MALF 354 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 63
  • PHOTO Orthosis, Limb Brace

Nearest event-volume peer: Orthosis, Limb Brace (1 report gap)

Mask, Oxygen sits #904 of 1000 among tracked device types with 456 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 2.0% corpus 1.5% · near corpus mean (+0.5 pp)
  • INJ 15.6% corpus 30.4% · below corpus mean (-14.9 pp)
  • MALF 77.6% corpus 64.5% · above corpus mean (+13.1 pp)

Lead product-problem code Disconnection is 21% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 61% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Mask, Oxygen in the event-volume neighbourhood

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

reports

What this shows Mask, Oxygen carries 456 MAUDE reports, ranked #904 of 1000.

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

Event Types

Malfunction 354 (77.6%)
Injury 71 (15.6%)
Other 19 (4.2%)
Death 9 (2.0%)
3 (0.7%)

Patient Outcomes

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

344 (72.3%)
Other 52 (10.9%)
Required Intervention 29 (6.1%)
R 14 (2.9%)
Hospitalization 11 (2.3%)
Death 9 (1.9%)
Life Threatening 8 (1.7%)
L 5 (1.1%)
Disability 3 (0.6%)
S 1 (0.2%)

Top Product Problems

Disconnection 32
Detachment of Device or Device Component 24
Connection Problem 14
Inflation Problem 14
Material Split, Cut or Torn 8
Nonstandard Device 7
Obstruction of Flow 7
Loose or Intermittent Connection 6
Break 5
Material Deformation 5
Detachment Of Device Component 4
Fitting Problem 4
Gas/Air Leak 4
Adverse Event Without Identified Device or Use Problem 3
Defective Component 3
Device Dislodged or Dislocated 3
Failure to Seal 3
Insufficient Information 3
Leak/Splash 3
Material Puncture/Hole 3

Yearly Trend

92
1992: 2
93
1993: 2
96
1996: 5
97
1997: 7
98
1998: 3
99
1999: 1
00
2000: 3
01
2001: 3
02
2002: 5
03
2003: 6
04
2004: 2
05
2005: 4
06
2006: 12
07
2007: 17
08
2008: 16
09
2009: 14
10
2010: 13
11
2011: 16
12
2012: 19
13
2013: 20
14
2014: 51
15
2015: 63
16
2016: 22
17
2017: 8
18
2018: 39
19
2019: 29
20
2020: 6
21
2021: 12
22
2022: 18
23
2023: 4
24
2024: 9
25
2025: 24
26
2026: 1

Related Entities for Mask, Oxygen

Top Manufacturers

TELEFLEX MEDICAL 135
FISHER & PAYKEL HEALTHCARE LTD 51
CAREFUSION 25
FISHER & PAYKEL HEALTHCARE, LTD. 11

Event Locations

247 (54.2%)
I 138 (30.3%)
HOSPITAL 39 (8.6%)
NO INFORMATION 12 (2.6%)
HOME 6 (1.3%)
INVALID DATA 5 (1.1%)
NOT APPLICABLE 3 (0.7%)
AMBULATORY SURGICAL FACILITY 2 (0.4%)
NURSING HOME 2 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare TELEFLEX MEDICAL vs FISHER & PAYKEL HEALTHCARE LTD →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Mask, Oxygen, 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 (456 here).

Orthosis, Limb Brace 455 Infant Heel Warmer 454 Test, Natriuretic Peptide 459 Tubing, Pressure And Accessories 459

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Choledochoscope And Accessories 9 Connector, Airway 9

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

Disclaimer: MAUDE figures for Mask, Oxygen 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 Mask, Oxygen; 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.