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2026 data FDA MAUDE openFDA FDA Class I

Set, Tubing And Support, Ventilator (W Harness)

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 §868.5975 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Set, Tubing And Support, Ventilator LIGHT-BOOK · MAUDE

#544 of 1000 · 1,654 reports · 1992–2026

  • BOOK 1,654 reports
  • RANK #544 of 1000
  • DEATH 22 death-typed
  • INJ 134 injury-typed
  • MALF 1,441 malfunction
  • SPAN 1992–2026
  • PEAK 2011: 186
  • PHOTO Processor

Nearest event-volume peer: Processor, Tissue, Automated (3 report gap)

Set, Tubing And Support, Ventilator (W Harness) sits #544 of 1000 among tracked device types with 1,654 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 →

Malfunction reports run above the device-type norm

Set, Tubing And Support, Ventilator carries 87.1% MALFUNCTION-coded reports, 22.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 8.1% corpus 30.3% · below corpus mean (-22.2 pp)
  • MALF 87.1% corpus 64.8% · above corpus mean (+22.3 pp)

Lead product-problem code Leak/Splash is 17% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 50% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Set, Tubing And Support, Ventilator in the event-volume neighbourhood

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

reports

What this shows Set, Tubing And Support, Ventilator (W Harness) carries 1,654 MAUDE reports, ranked #544 of 1000.

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

Event Types

Malfunction 1,441 (87.1%)
Injury 134 (8.1%)
Other 35 (2.1%)
22 (1.3%)
Death 22 (1.3%)

Patient Outcomes

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

1,362 (80.6%)
Other 122 (7.2%)
Required Intervention 111 (6.6%)
Life Threatening 25 (1.5%)
R 19 (1.1%)
Death 18 (1.1%)
L 9 (0.5%)
Disability 8 (0.5%)
S 7 (0.4%)
Hospitalization 6 (0.4%)
O 2 (0.1%)
H 1 (0.1%)

Top Product Problems

Leak/Splash 246
Material Split, Cut or Torn 162
Break 150
Crack 129
Melted 103
Obstruction of Flow 89
Disconnection 79
Device Operates Differently Than Expected 77
Hole In Material 58
Gas/Air Leak 53
Air Leak 44
Device Issue 44
Detachment Of Device Component 37
Split 27
Loose or Intermittent Connection 26
Torn Material 25
Insufficient Device Problem Information 24
Physical Resistance/Sticking 24
Detachment of Device or Device Component 23
Replace 22

Yearly Trend

92
1992: 1
93
1993: 6
94
1994: 15
95
1995: 27
96
1996: 23
97
1997: 37
98
1998: 31
99
1999: 12
00
2000: 15
01
2001: 17
02
2002: 5
03
2003: 10
04
2004: 14
05
2005: 15
06
2006: 17
07
2007: 43
08
2008: 41
09
2009: 46
10
2010: 140
11
2011: 186
12
2012: 99
13
2013: 122
14
2014: 84
15
2015: 55
16
2016: 56
17
2017: 46
18
2018: 26
19
2019: 33
20
2020: 30
21
2021: 52
22
2022: 66
23
2023: 37
24
2024: 45
25
2025: 71
26
2026: 131

Reports rose to 71 in 2025, up from an average of 41 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Set, Tubing And Support, Ventilator (W Harness)

Top Manufacturers

TELEFLEX MEDICAL 494
FISHER & PAYKEL HEALTHCARE LTD 291
HAMILTON MEDICAL AG 89
FISHER & PAYKEL HEALTHCARE, LTD. 58
CARDINAL HEALTH 34
CAREFUSION 28

Event Locations

1,169 (70.7%)
I 241 (14.6%)
HOSPITAL 188 (11.4%)
OTHER 16 (1.0%)
INVALID DATA 15 (0.9%)
UNKNOWN 7 (0.4%)
HOME 6 (0.4%)
NURSING HOME 6 (0.4%)
NO INFORMATION 5 (0.3%)
NOT APPLICABLE 1 (0.1%)

Compare TELEFLEX MEDICAL vs FISHER & PAYKEL HEALTHCARE LTD →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Set, Tubing And Support, Ventilator: 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 (1,654 here).

Processor, Tissue, Automated 1,657 Microfilter, Blood Transfusion 1,648 Retractor 1,646 Adhesive 1,663

Similar death-typed counts

Nearest other device types by death-typed report count (22 here), distinct from the volume row.

Accessories, Cleaning, For Endoscope 22 Charger, Pacemaker 22 Device, Thermal Ablation, Endometrial 22 Endoscopic Access Overtube 22

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

Disclaimer: MAUDE figures for Set, Tubing And Support, Ventilator 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 Set, Tubing And Support, Ventilator; 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.