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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Automated External Defibrillators HEAVY-BOOK · MAUDE

#16 of 1000 · 263,821 reports · 1992–2026

  • BOOK 263,821 reports
  • RANK #16 of 1000
  • DEATH 4,461 death-typed
  • INJ 1,871 injury-typed
  • MALF 255,404 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 17,063
  • PHOTO Ventilator

Nearest event-volume peer: Ventilator, Non-Continuous (Respirator) (1,257 report gap)

Automated External Defibrillators (Non-Wearable) sits #16 of 1000 among tracked device types with 263,821 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 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 0.7% corpus 30.4% · below corpus mean (-29.7 pp)
  • MALF 96.8% corpus 64.5% · above corpus mean (+32.3 pp)

Lead product-problem code Failure of Device to Self-Test is 17% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 38% of manufacturer-tagged reports · Top event location is 57% 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 263,821 MAUDE reports, ranked #16 of 1000.

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

Event Types

Malfunction 255,404 (96.8%)
Death 4,461 (1.7%)
Injury 1,871 (0.7%)
1,519 (0.6%)
Other 566 (0.2%)

Patient Outcomes

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

243,841 (92.4%)
Other 13,637 (5.2%)
Death 4,622 (1.8%)
Life Threatening 942 (0.4%)
Required Intervention 264 (0.1%)
O 110 (0.0%)
Hospitalization 108 (0.0%)
R 104 (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 of Device to Self-Test 21,398
Failure to Power Up 19,248
Device Operates Differently Than Expected 12,626
Unable to Obtain Readings 11,041
Defibrillation/Stimulation Problem 6,495
Device Displays Incorrect Message 6,424
No Display/Image 6,219
Battery Problem 5,185
Unexpected Shutdown 4,680
Electrical /Electronic Property Problem 4,664
Detachment of Device or Device Component 4,631
Failure to Deliver Shock/Stimulation 4,588
Self-Activation or Keying 3,520
Incorrect, Inadequate or Imprecise Result or Readings 3,404
Failure to Charge 3,386
Defective Device 2,911
Break 2,580
Therapeutic or Diagnostic Output Failure 2,215
Power Problem 2,105
Device Inoperable 1,882

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: 8,170
12
2012: 9,733
13
2013: 14,954
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: 2,021

Related Entities for Automated External Defibrillators (Non-Wearable)

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 88,365
ZOLL MEDICAL CORPORATION 72,871
PHYSIO-CONTROL, INC. - 3015876 20,743
PHILIPS NORTH AMERICA LLC 17,112
HEARTSINE TECHNOLOGIES LTD 8,219
PHYSIO-CONTROL, INC 8,046
CARDIAC SCIENCE CORPORATION 7,192
ZOLL MEDICAL CORP. 4,746
DEFIBTECH, L.L.C. 4,101
HEARTSINE TECHNOLOGIES, LTD 3,941

Event Locations

150,138 (56.9%)
I 97,504 (37.0%)
OUTPATIENT TREATMENT FACILITY 5,740 (2.2%)
HOSPITAL 4,012 (1.5%)
OTHER 3,666 (1.4%)
NO INFORMATION 830 (0.3%)
UNKNOWN 634 (0.2%)
SCHOOL 324 (0.1%)
PUBLIC BUILDING 189 (0.1%)
HOME 167 (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%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Automated External Defibrillators, 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 (263,821 here).

Ventilator, Non-Continuous 265,078 Sensor, Glucose, Invasive 280,884 Drug Eluting Permanent Right Ventricular Or… 218,060 Prosthesis 214,814

Similar death-typed counts

Nearest other device types by death-typed report count (4,461 here), distinct from the volume row.

Temporary Non-Roller Type Left Heart Suppor… 4,677 Defibrillator 4,732 Pulse Generator, Permanent, Implantable 3,860 Wearable Automated External Defibrillator 3,639

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.