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2026 data FDA MAUDE openFDA FDA Class III

Automated External Defibrillators (Non-Wearable)

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 III (highest risk, premarket approval required), regulated under 21 CFR §870.5310 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Automated External Defibrillators HEAVY-BOOK · MAUDE

#17 of 1000 · 268,697 reports · 1992–2026

  • BOOK 268,697 reports
  • RANK #17 of 1000
  • DEATH 4,510 death-typed
  • INJ 1,937 injury-typed
  • MALF 260,163 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 17,063
  • PHOTO Sensor

Nearest event-volume peer: Sensor, Glucose, Invasive (13,244 report gap)

Automated External Defibrillators (Non-Wearable) sits #17 of 1000 among tracked device types with 268,697 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

Automated External Defibrillators carries 96.8% MALFUNCTION-coded reports, 32.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 0.7% corpus 30.3% · below corpus mean (-29.6 pp)
  • MALF 96.8% corpus 64.8% · above corpus mean (+32.0 pp)

Lead product-problem code Failure to Power Up is 16% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 37% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Automated External Defibrillators in the event-volume neighbourhood

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

reports

What this shows Automated External Defibrillators (Non-Wearable) carries 268,697 MAUDE reports, ranked #17 of 1000.

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

Event Types

Malfunction 260,163 (96.8%)
Death 4,510 (1.7%)
Injury 1,937 (0.7%)
1,519 (0.6%)
Other 568 (0.2%)

Patient Outcomes

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

248,498 (92.5%)
Other 13,700 (5.1%)
Death 4,670 (1.7%)
Life Threatening 961 (0.4%)
Required Intervention 269 (0.1%)
Hospitalization 116 (0.0%)
O 112 (0.0%)
R 106 (0.0%)
L 75 (0.0%)
Disability 40 (0.0%)
D 21 (0.0%)
S 14 (0.0%)
Congenital Anomaly 14 (0.0%)
H 12 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Failure to Power Up 34,751
Device Operates Differently Than Expected 31,833
Device Displays Incorrect Message 31,217
Failure of Device to Self-Test 23,960
Unable to Obtain Readings 11,765
No Display/Image 11,317
Defibrillation/Stimulation Problem 8,631
Self-Activation or Keying 8,041
Failure to Charge 6,719
Battery Problem 6,710
Device Inoperable 5,101
Electrical /Electronic Property Problem 4,967
Unexpected Shutdown 4,921
Failure to Deliver Shock/Stimulation 4,885
Detachment of Device or Device Component 4,877
Failure to Discharge 4,435
Loss of Power 4,389
Break 3,711
Incorrect, Inadequate or Imprecise Result or Readings 3,450
Defective Device 3,154

Yearly Trend

92
1992: 1
93
1993: 3
94
1994: 5
95
1995: 19
96
1996: 142
97
1997: 372
98
1998: 646
99
1999: 694
00
2000: 714
01
2001: 1,469
02
2002: 1,758
03
2003: 2,104
04
2004: 2,913
05
2005: 3,338
06
2006: 3,432
07
2007: 3,958
08
2008: 4,752
09
2009: 6,782
10
2010: 7,399
11
2011: 8,171
12
2012: 9,732
13
2013: 14,955
14
2014: 15,399
15
2015: 16,129
16
2016: 17,063
17
2017: 16,684
18
2018: 16,591
19
2019: 16,861
20
2020: 16,197
21
2021: 16,300
22
2022: 14,867
23
2023: 13,766
24
2024: 15,113
25
2025: 13,472
26
2026: 6,896

Reports in 2025 (13,472) held close to the prior two-year average of 14,440.

Related Entities for Automated External Defibrillators (Non-Wearable)

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 88,431
ZOLL MEDICAL CORPORATION 74,850
PHYSIO-CONTROL, INC. - 3015876 21,788
PHILIPS NORTH AMERICA LLC 17,342
HEARTSINE TECHNOLOGIES LTD 8,270
PHYSIO-CONTROL, INC 8,046
CARDIAC SCIENCE CORPORATION 7,492
DEFIBTECH, L.L.C. 5,067
ZOLL MEDICAL CORP. 4,746
HEARTSINE TECHNOLOGIES, LTD 3,941

Event Locations

155,006 (57.7%)
I 97,501 (36.3%)
OUTPATIENT TREATMENT FACILITY 5,740 (2.1%)
HOSPITAL 4,022 (1.5%)
OTHER 3,666 (1.4%)
NO INFORMATION 829 (0.3%)
UNKNOWN 634 (0.2%)
SCHOOL 324 (0.1%)
PUBLIC BUILDING 189 (0.1%)
HOME 168 (0.1%)
CLINIC - WALK IN, OTHER 114 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 102 (0.0%)
PUBLIC VENUE 83 (0.0%)
STREET 57 (0.0%)
AMBULATORY HEALTH CARE FACILITY 47 (0.0%)
NURSING HOME 44 (0.0%)
INVALID DATA 37 (0.0%)
NOT APPLICABLE 30 (0.0%)
PARK 20 (0.0%)
AMBULATORY SURGICAL FACILITY 19 (0.0%)
IN TRANSIT TO USER/MEDICAL FACILITY 19 (0.0%)
REHABILITATION CENTER 10 (0.0%)
OUTDOORS 8 (0.0%)
RETIREMENT HOME 7 (0.0%)
DIALYSIS CENTER 3 (0.0%)
RADIOLOGY DEPARTMENT 3 (0.0%)
AMBULATORY SURGICAL CENTER 2 (0.0%)
DRUG CLINIC 2 (0.0%)
LONG-TERM CARE FACILITY 2 (0.0%)
MRI CENTERS 2 (0.0%)
0 1 (0.0%)
HOSPICE 1 (0.0%)
LABORATORY 1 (0.0%)
MATERNITY WARD - NURSERY 1 (0.0%)
PSYCHIATRIC CENTER - WALK IN, OTHER 1 (0.0%)
PSYCHIATRIC FACILITY 1 (0.0%)
URGENT CARE CENTER 1 (0.0%)

Compare PHILIPS MEDICAL SYSTEMS vs ZOLL MEDICAL CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Automated External Defibrillators: 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 (268,697 here).

Sensor, Glucose, Invasive 281,941 Ventilator, Non-Continuous 300,898 Prosthesis 229,178 Drug Eluting Permanent Right Ventricular Or… 228,094

Similar death-typed counts

Nearest other device types by death-typed report count (4,510 here), distinct from the volume row.

Defibrillator 4,802 Pulse Generator, Permanent, Implantable 3,912 Wearable Automated External Defibrillator 3,738 System, Peritoneal, Automatic Delivery 3,434

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

Disclaimer: MAUDE figures for Automated External Defibrillators 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 Automated External Defibrillators; 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.