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2026 data FDA MAUDE openFDA FDA Class II

Ventilator, Emergency, Manual (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 §868.5915 (Anesthesiology panel).

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FDA MAUDE casebook

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

#511 of 1000 · 1,891 reports · 1993–2026

  • BOOK 1,891 reports
  • RANK #511 of 1000
  • DEATH 164 death-typed
  • INJ 328 injury-typed
  • MALF 1,295 malfunction
  • SPAN 1993–2026
  • PEAK 2001: 116
  • PHOTO Calculator, Drug Dose

Nearest event-volume peer: Calculator, Drug Dose (7 report gap)

Ventilator, Emergency, Manual (Resuscitator) sits #511 of 1000 among tracked device types with 1,891 MAUDE reports spanning 1993–2026. 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

Ventilator, Emergency, Manual carries 17.3% INJURY-coded reports, 12.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 8.7% corpus 1.5% · above corpus mean (+7.2 pp)
  • INJ 17.3% corpus 30.3% · below corpus mean (-12.9 pp)
  • MALF 68.5% corpus 64.8% · above corpus mean (+3.7 pp)

Lead product-problem code Replace is 13% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 56% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Ventilator, Emergency, Manual in the event-volume neighbourhood

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

reports

What this shows Ventilator, Emergency, Manual (Resuscitator) carries 1,891 MAUDE reports, ranked #511 of 1000.

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

Event Types

Malfunction 1,295 (68.5%)
Injury 328 (17.3%)
Death 164 (8.7%)
Other 67 (3.5%)
37 (2.0%)

Patient Outcomes

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

1,122 (55.9%)
Other 285 (14.2%)
Required Intervention 202 (10.1%)
Death 153 (7.6%)
Life Threatening 84 (4.2%)
R 47 (2.3%)
L 29 (1.4%)
Hospitalization 26 (1.3%)
O 22 (1.1%)
S 16 (0.8%)
Disability 13 (0.6%)
H 4 (0.2%)
Invalid Data 2 (0.1%)
D 1 (0.0%)
Not Applicable 1 (0.0%)

Top Product Problems

Replace 212
Component Missing 176
Detachment Of Device Component 115
Device Issue 108
Inflation Problem 100
Failure to Deliver 99
Break 96
Disconnection 90
No Flow 87
Material Separation 66
Defective Device 61
Air Leak 56
Fitting Problem 48
Sticking 48
Valve(s), sticking 48
Out-Of-Box Failure 46
Device Operates Differently Than Expected 44
Misassembled 41
Valve(s), failure of 39
Deflation Problem 35

Yearly Trend

93
1993: 2
94
1994: 21
95
1995: 24
96
1996: 68
97
1997: 98
98
1998: 82
99
1999: 82
00
2000: 87
01
2001: 116
02
2002: 105
03
2003: 74
04
2004: 66
05
2005: 65
06
2006: 58
07
2007: 65
08
2008: 31
09
2009: 21
10
2010: 23
11
2011: 48
12
2012: 68
13
2013: 44
14
2014: 108
15
2015: 36
16
2016: 92
17
2017: 56
18
2018: 56
19
2019: 46
20
2020: 26
21
2021: 42
22
2022: 35
23
2023: 46
24
2024: 33
25
2025: 36
26
2026: 31

Reports in 2025 (36) held close to the prior two-year average of 40.

Related Entities for Ventilator, Emergency, Manual (Resuscitator)

Top Manufacturers

TELEFLEX MEDICAL 94
CAREFUSION 74

Event Locations

949 (50.2%)
HOSPITAL 534 (28.2%)
I 251 (13.3%)
INVALID DATA 58 (3.1%)
UNKNOWN 28 (1.5%)
OTHER 27 (1.4%)
NO INFORMATION 22 (1.2%)
HOME 5 (0.3%)
AMBULATORY SURGICAL FACILITY 4 (0.2%)
NOT APPLICABLE 4 (0.2%)
OUTPATIENT TREATMENT FACILITY 4 (0.2%)
IN TRANSIT TO USER/MEDICAL FACILITY 2 (0.1%)
NURSING HOME 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)

Compare TELEFLEX MEDICAL vs CAREFUSION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ventilator, Emergency, Manual: 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 (1,891 here).

Calculator, Drug Dose 1,898 Sterilant, Medical Devices 1,870 Bed 1,867 Tubing, Pump, Cardiopulmonary Bypass 1,866

Similar death-typed counts

Nearest other device types by death-typed report count (164 here), distinct from the volume row.

Tube Tracheostomy And Tube Cuff 164 Tube, Tracheostomy 163 Dialyzer, Capillary, Hollow Fiber 157 Mattress 154

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

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