2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#324 of 1000 · 4,700 reports · 1992–2026

  • BOOK 4,700 reports
  • RANK #324 of 1000
  • DEATH 34 death-typed
  • INJ 164 injury-typed
  • MALF 4,461 malfunction
  • SPAN 1992–2026
  • PEAK 2022: 755
  • PHOTO Staple, Removable

Nearest event-volume peer: Staple, Removable (Skin) (13 report gap)

Ventilator, Emergency, Powered (Resuscitator) sits #324 of 1000 among tracked device types with 4,700 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 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 3.5% corpus 30.4% · below corpus mean (-26.9 pp)
  • MALF 94.9% corpus 64.5% · above corpus mean (+30.4 pp)

Lead product-problem code Pressure Problem is 21% of coded problems · Lead manufacturer FISHER & PAYKEL HEALTHCARE LTD accounts for 36% 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 4,700 MAUDE reports, ranked #324 of 1000.

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

Event Types

Malfunction 4,461 (94.9%)
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.

4,421 (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

Pressure Problem 721
Break 712
Device Alarm System 287
Failure to Cycle 229
Gas/Air Leak 165
Tidal Volume Fluctuations 153
Mechanical Problem 146
Defective Component 122
Loose or Intermittent Connection 112
Component Missing 95
No Audible Alarm 91
Detachment of Device or Device Component 86
Defective Device 78
Defective Alarm 75
Output Problem 73
Battery Problem 69
Device Issue 69
Noise, Audible 67
Crack 63
Incorrect, Inadequate or Imprecise Result or Readings 62

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: 95
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: 14

Related Entities for Ventilator, Emergency, Powered (Resuscitator)

Event Locations

3,057 (65.0%)
I 1,509 (32.1%)
HOSPITAL 92 (2.0%)
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 INTERNATIONAL, LTD. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Ventilator, Emergency, Powered, 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 (4,700 here).

Similar death-typed counts

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

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.