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2026 data FDA MAUDE openFDA FDA Class I

Regulator, Pressure, Gas Cylinder

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 §868.2700 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Regulator, Pressure, Gas Cylinder LIGHT-BOOK · MAUDE

#805 of 1000 · 646 reports · 1992–2026

  • BOOK 646 reports
  • RANK #805 of 1000
  • DEATH 23 death-typed
  • INJ 103 injury-typed
  • MALF 474 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 238
  • PHOTO Aberrometer

Nearest event-volume peer: Aberrometer, Ophthalmic (3 report gap)

Regulator, Pressure, Gas Cylinder sits #805 of 1000 among tracked device types with 646 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

Regulator, Pressure, Gas Cylinder carries 15.9% INJURY-coded reports, 14.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.6% corpus 1.5% · above corpus mean (+2.1 pp)
  • INJ 15.9% corpus 30.3% · below corpus mean (-14.3 pp)
  • MALF 73.4% corpus 64.8% · above corpus mean (+8.5 pp)

Lead product-problem code Break is 13% of coded problems · Lead manufacturer MEDLINE INDUSTRIES, LP accounts for 100% of manufacturer-tagged reports · Top event location NO INFORMATION is 39% of location-tagged rows .

Regulator, Pressure, Gas Cylinder in the event-volume neighbourhood

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

reports

What this shows Regulator, Pressure, Gas Cylinder carries 646 MAUDE reports, ranked #805 of 1000.

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

Event Types

Malfunction 474 (73.4%)
Injury 103 (15.9%)
Other 26 (4.0%)
Death 23 (3.6%)
20 (3.1%)

Patient Outcomes

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

295 (43.3%)
Other 232 (34.1%)
Required Intervention 38 (5.6%)
Hospitalization 32 (4.7%)
Death 23 (3.4%)
Life Threatening 21 (3.1%)
R 18 (2.6%)
L 6 (0.9%)
O 5 (0.7%)
S 4 (0.6%)
H 3 (0.4%)
Disability 3 (0.4%)
Invalid Data 1 (0.1%)

Top Product Problems

Break 157
Gas/Air Leak 148
Device Emits Odor 138
High Test Results 128
Improper Flow or Infusion 98
Loose or Intermittent Connection 97
Increase in Pressure 95
Separation Problem 90
Fire 70
Gas Output Problem 28
Explode 18
Other (for use when an appropriate device code cannot be identified) 17
Replace 15
Leak/Splash 14
Device Operates Differently Than Expected 13
Noise 13
Use of Device Problem 13
Material Separation 12
Detachment Of Device Component 10
Unknown (for use when the device problem is not known) 10

Yearly Trend

92
1992: 2
94
1994: 8
95
1995: 3
96
1996: 7
97
1997: 22
98
1998: 8
99
1999: 25
00
2000: 17
01
2001: 12
02
2002: 10
03
2003: 19
04
2004: 22
05
2005: 16
07
2007: 2
08
2008: 8
09
2009: 5
10
2010: 7
11
2011: 5
12
2012: 23
13
2013: 6
14
2014: 12
15
2015: 12
16
2016: 13
17
2017: 11
18
2018: 238
19
2019: 20
20
2020: 2
21
2021: 6
22
2022: 6
23
2023: 19
24
2024: 59
25
2025: 4
26
2026: 17

Reports fell to 4 in 2025, down from an average of 39 in the two years before.

Related Entities for Regulator, Pressure, Gas Cylinder

Top Manufacturers

MEDLINE INDUSTRIES, LP 14

Event Locations

NO INFORMATION 252 (39.0%)
192 (29.7%)
HOSPITAL 103 (15.9%)
I 35 (5.4%)
OTHER 17 (2.6%)
HOME 15 (2.3%)
INVALID DATA 10 (1.5%)
UNKNOWN 9 (1.4%)
NOT APPLICABLE 3 (0.5%)
NURSING HOME 3 (0.5%)
OUTPATIENT TREATMENT FACILITY 3 (0.5%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
OUTDOORS 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
PUBLIC VENUE 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Regulator, Pressure, Gas Cylinder: 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 (646 here).

Aberrometer, Ophthalmic 649 Floss, Dental 649 Chair, Examination And Treatment 652 Prostate-Specific Antigen For Management Of… 653

Similar death-typed counts

Nearest other device types by death-typed report count (23 here), distinct from the volume row.

Cannula, Catheter 23 Electrode, Electrocardiograph 23 Gastrointestinal Tubes With Enteral Specifi… 23 Transducer, Ultrasonic, Diagnostic 23

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

Disclaimer: MAUDE figures for Regulator, Pressure, Gas Cylinder 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 Regulator, Pressure, Gas Cylinder; 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.