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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#500 of 1000 · 1,864 reports · 1993–2026

  • BOOK 1,864 reports
  • RANK #500 of 1000
  • DEATH 162 death-typed
  • INJ 323 injury-typed
  • MALF 1,275 malfunction
  • SPAN 1993–2026
  • PEAK 2001: 116
  • PHOTO Sterilant

Nearest event-volume peer: Sterilant, Medical Devices (2 report gap)

Ventilator, Emergency, Manual (Resuscitator) sits #500 of 1000 among tracked device types with 1,864 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 →

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 8.7% corpus 1.5% · above corpus mean (+7.2 pp)
  • INJ 17.3% corpus 30.4% · below corpus mean (-13.1 pp)
  • MALF 68.4% corpus 64.5% · above corpus mean (+3.9 pp)

Lead product-problem code Break 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 1,864 MAUDE reports, ranked #500 of 1000.

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

Event Types

Malfunction 1,275 (68.4%)
Injury 323 (17.3%)
Death 162 (8.7%)
Other 67 (3.6%)
37 (2.0%)

Patient Outcomes

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

1,111 (55.9%)
Other 276 (13.9%)
Required Intervention 201 (10.1%)
Death 153 (7.7%)
Life Threatening 82 (4.1%)
R 48 (2.4%)
L 29 (1.5%)
Hospitalization 26 (1.3%)
O 22 (1.1%)
S 16 (0.8%)
Disability 13 (0.7%)
H 5 (0.3%)
Invalid Data 2 (0.1%)
D 1 (0.1%)
Not Applicable 1 (0.1%)

Top Product Problems

Break 44
Device Issue 31
Inflation Problem 29
Device Operates Differently Than Expected 21
Separation Failure 21
Device Operational Issue 20
Deflation Problem 18
Defective Device 17
Device Damaged Prior to Use 16
Difficult to Remove 16
Material Integrity Problem 15
Appropriate Term/Code Not Available 14
Connection Problem 14
Defective Component 14
Component Missing 13
Gas/Air Leak 11
Crack 10
Detachment of Device or Device Component 10
Fitting Problem 9
No Flow 9

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: 4

Related Entities for Ventilator, Emergency, Manual (Resuscitator)

Top Manufacturers

TELEFLEX MEDICAL 94
CAREFUSION 74

Event Locations

926 (49.7%)
HOSPITAL 530 (28.4%)
I 251 (13.5%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Ventilator, Emergency, Manual, 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 (1,864 here).

Sterilant, Medical Devices 1,862 Disinfectant, Medical Devices 1,854 Tubing, Pump, Cardiopulmonary Bypass 1,852 Radioimmunoassay, Free Thyroxine 1,849

Similar death-typed counts

Nearest other device types by death-typed report count (162 here), distinct from the volume row.

Tube, Tracheostomy 162 Tube Tracheostomy And Tube Cuff 161 Dilator 165 Dialyzer, Capillary, Hollow Fiber 157

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.