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2026 data FDA MAUDE openFDA FDA Class I

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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §868.5580 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Mask, Oxygen LIGHT-BOOK · MAUDE

#916 of 1000 · 470 reports · 1992–2026

  • BOOK 470 reports
  • RANK #916 of 1000
  • DEATH 9 death-typed
  • INJ 76 injury-typed
  • MALF 363 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 63
  • PHOTO Implantable Transpros…

Nearest event-volume peer: Implantable Transprostatic Tissue Retractor System (1 report gap)

Mask, Oxygen sits #916 of 1000 among tracked device types with 470 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 →

Injury-coded reports sit below the device-type norm

Mask, Oxygen carries 16.2% INJURY-coded reports, 14.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.9% corpus 1.5% · near corpus mean (+0.4 pp)
  • INJ 16.2% corpus 30.3% · below corpus mean (-14.1 pp)
  • MALF 77.2% corpus 64.8% · above corpus mean (+12.4 pp)

Lead product-problem code Detachment of Device or Device Component is 17% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 58% of manufacturer-tagged reports · Top event location is 55% 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 470 MAUDE reports, ranked #916 of 1000.

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

Event Types

Malfunction 363 (77.2%)
Injury 76 (16.2%)
Other 19 (4.0%)
Death 9 (1.9%)
3 (0.6%)

Patient Outcomes

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

352 (71.8%)
Other 57 (11.6%)
Required Intervention 29 (5.9%)
R 14 (2.9%)
Hospitalization 11 (2.2%)
Death 9 (1.8%)
Life Threatening 9 (1.8%)
L 5 (1.0%)
Disability 3 (0.6%)
S 1 (0.2%)

Top Product Problems

Detachment of Device or Device Component 61
Disconnection 43
Detachment Of Device Component 40
Connection Problem 30
Inflation Problem 19
Occlusion Within Device 18
Break 17
Loose or Intermittent Connection 16
Insufficient Device Problem Information 13
Material Integrity Problem 11
Component(s), broken 9
Fire 9
Material Split, Cut or Torn 9
Device Operates Differently Than Expected 8
Inadequacy of Device Shape and/or Size 8
Leak/Splash 8
No Flow 8
Nonstandard Device 8
Partial Blockage 8
Unknown (for use when the device problem is not known) 8

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: 15

Reports rose to 24 in 2025, up from an average of 7 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Mask, Oxygen

Top Manufacturers

TELEFLEX MEDICAL 135
FISHER & PAYKEL HEALTHCARE LTD 52
CAREFUSION 25
FISHER & PAYKEL HEALTHCARE, LTD. 11
MEDLINE INDUSTRIES, LP 10

Event Locations

258 (54.9%)
I 138 (29.4%)
HOSPITAL 42 (8.9%)
NO INFORMATION 12 (2.6%)
HOME 6 (1.3%)
INVALID DATA 5 (1.1%)
NOT APPLICABLE 3 (0.6%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Mask, Oxygen: 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 (470 here).

Implantable Transprostatic Tissue Retractor… 471 Clip, Hemostatic 468 Laparoscope 468 System, Identification, Hepatitis B Antigen 472

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.