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2026 data FDA MAUDE openFDA FDA Class II

Ventilator, Emergency, Powered (Resuscitator)

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 II (moderate risk, special controls required), regulated under 21 CFR §868.5925 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Ventilator, Emergency, Powered LIGHT-BOOK · MAUDE

#329 of 1000 · 4,749 reports · 1992–2026

  • BOOK 4,749 reports
  • RANK #329 of 1000
  • DEATH 34 death-typed
  • INJ 164 injury-typed
  • MALF 4,510 malfunction
  • SPAN 1992–2026
  • PEAK 2022: 755
  • PHOTO Staple, Removable

Nearest event-volume peer: Staple, Removable (Skin) (6 report gap)

Ventilator, Emergency, Powered (Resuscitator) sits #329 of 1000 among tracked device types with 4,749 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

Ventilator, Emergency, Powered carries 95.0% MALFUNCTION-coded reports, 30.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 3.5% corpus 30.3% · below corpus mean (-26.8 pp)
  • MALF 95.0% corpus 64.8% · above corpus mean (+30.1 pp)

Lead product-problem code Break is 23% of coded problems · Lead manufacturer FISHER & PAYKEL HEALTHCARE LTD accounts for 53% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Ventilator, Emergency, Powered in the event-volume neighbourhood

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

reports

What this shows Ventilator, Emergency, Powered (Resuscitator) carries 4,749 MAUDE reports, ranked #329 of 1000.

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

Event Types

Malfunction 4,510 (95.0%)
Injury 164 (3.5%)
Death 34 (0.7%)
Other 28 (0.6%)
13 (0.3%)

Patient Outcomes

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

4,450 (93.1%)
Required Intervention 110 (2.3%)
Other 91 (1.9%)
R 52 (1.1%)
Death 36 (0.8%)
Life Threatening 23 (0.5%)
Hospitalization 5 (0.1%)
L 3 (0.1%)
Invalid Data 3 (0.1%)
Disability 2 (0.0%)
O 1 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 899
Pressure Problem 774
Device Alarm System 305
Failure to Cycle 254
Gas/Air Leak 171
Tidal Volume Fluctuations 156
Mechanical Problem 149
Defective Component 132
Loose or Intermittent Connection 119
Detachment of Device or Device Component 111
Component Missing 98
No Audible Alarm 92
Defective Device 91
Device Issue 88
Device Operates Differently Than Expected 84
Crack 83
Defective Alarm 76
Output Problem 73
Battery Problem 72
Noise, Audible 71

Yearly Trend

92
1992: 5
93
1993: 9
94
1994: 10
95
1995: 2
96
1996: 1
99
1999: 1
00
2000: 2
02
2002: 1
03
2003: 1
04
2004: 1
05
2005: 2
06
2006: 3
07
2007: 5
08
2008: 37
09
2009: 69
10
2010: 96
11
2011: 75
12
2012: 115
13
2013: 103
14
2014: 70
15
2015: 79
16
2016: 80
17
2017: 101
18
2018: 197
19
2019: 341
20
2020: 454
21
2021: 506
22
2022: 755
23
2023: 731
24
2024: 667
25
2025: 168
26
2026: 62

Reports fell to 168 in 2025, down from an average of 699 in the two years before.

Related Entities for Ventilator, Emergency, Powered (Resuscitator)

Top Manufacturers

FISHER & PAYKEL HEALTHCARE LTD 1,103
SMITHS MEDICAL ASD, INC. 585
ST PAUL 249
FISHER & PAYKEL HEALTHCARE, LTD. 107
ICU MEDICAL, INC. 53

Event Locations

3,106 (65.4%)
I 1,509 (31.8%)
HOSPITAL 92 (1.9%)
OTHER 23 (0.5%)
NO INFORMATION 11 (0.2%)
INVALID DATA 5 (0.1%)
HOME 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare FISHER & PAYKEL HEALTHCARE LTD vs SMITHS MEDICAL ASD, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ventilator, Emergency, Powered: 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 (4,749 here).

Staple, Removable 4,743 Closed Antineoplastic And Hazardous Drug Re… 4,732 Mesh 4,774 System, Nuclear Magnetic Resonance Imaging 4,713

Similar death-typed counts

Nearest other device types by death-typed report count (34 here), distinct from the volume row.

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 34 Insufflator, Laparoscopic 34 Intrasaccular Flow Disruption Device 34 Prosthesis 34

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

Disclaimer: MAUDE figures for Ventilator, Emergency, Powered 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 Ventilator, Emergency, Powered; 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.