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2026 data FDA MAUDE openFDA FDA Class III

Wearable Automated External Defibrillator

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

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FDA MAUDE casebook

openFDA event book Wearable Automated External Defibrillator HEAVY-BOOK · MAUDE

#29 of 1000 · 148,775 reports · 2002–2026

  • BOOK 148,775 reports
  • RANK #29 of 1000
  • DEATH 3,738 death-typed
  • INJ 36,281 injury-typed
  • MALF 108,745 malfunction
  • SPAN 2002–2026
  • PEAK 2023: 12,988
  • PHOTO Implantable Pulse Gen…

Nearest event-volume peer: Implantable Pulse Generator, Pacemaker (Non-Crt) (7,594 report gap)

Wearable Automated External Defibrillator sits #29 of 1000 among tracked device types with 148,775 MAUDE reports spanning 2002–2026. 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

Wearable Automated External Defibrillator carries 73.1% MALFUNCTION-coded reports, 8.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.5% corpus 1.5% · above corpus mean (+1.0 pp)
  • INJ 24.4% corpus 30.3% · below corpus mean (-5.9 pp)
  • MALF 73.1% corpus 64.8% · above corpus mean (+8.3 pp)

Lead product-problem code Battery Problem is 11% of coded problems · Lead manufacturer ZOLL MANUFACTURING CORPORATION accounts for 90% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Wearable Automated External Defibrillator in the event-volume neighbourhood

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

reports

What this shows Wearable Automated External Defibrillator carries 148,775 MAUDE reports, ranked #29 of 1000.

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

Event Types

Malfunction 108,745 (73.1%)
Injury 36,281 (24.4%)
Death 3,738 (2.5%)
9 (0.0%)
Other 2 (0.0%)

Patient Outcomes

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

120,322 (74.7%)
Other 12,244 (7.6%)
Hospitalization 7,408 (4.6%)
O 6,155 (3.8%)
R 5,765 (3.6%)
Required Intervention 4,501 (2.8%)
Death 3,952 (2.5%)
H 470 (0.3%)
Disability 88 (0.1%)
S 69 (0.0%)
Life Threatening 39 (0.0%)
L 33 (0.0%)
D 16 (0.0%)
Congenital Anomaly 9 (0.0%)

Top Product Problems

Battery Problem 15,472
Failure to Power Up 15,131
Inappropriate/Inadequate Shock/Stimulation 13,656
Device Displays Incorrect Message 13,643
Adverse Event Without Identified Device or Use Problem 7,634
Circuit Failure 7,619
Break 6,749
Device Operates Differently Than Expected 6,334
Patient Device Interaction Problem 6,331
Signal Artifact/Noise 6,040
Charging Problem 4,851
Failure to Charge 4,166
Incorrect Interpretation of Signal 3,921
Key or Button Unresponsive/not Working 3,765
Device Inoperable 3,712
Over-Sensing 3,441
Patient-Device Incompatibility 3,392
Protective Measures Problem 3,012
Structural Problem 3,000
Contamination /Decontamination Problem 2,940

Yearly Trend

02
2002: 30
03
2003: 53
04
2004: 19
05
2005: 95
06
2006: 144
07
2007: 446
08
2008: 690
09
2009: 946
10
2010: 1,363
11
2011: 1,975
12
2012: 3,375
13
2013: 3,805
14
2014: 5,086
15
2015: 8,415
16
2016: 9,463
17
2017: 10,853
18
2018: 9,941
19
2019: 9,894
20
2020: 11,904
21
2021: 12,466
22
2022: 12,667
23
2023: 12,988
24
2024: 12,585
25
2025: 12,292
26
2026: 7,280

Reports in 2025 (12,292) held close to the prior two-year average of 12,787.

Related Entities for Wearable Automated External Defibrillator

Top Manufacturers

ZOLL MANUFACTURING CORPORATION 131,938
ZOLL LIFECOR CORPORATION 13,683
ZOLL Manufacturing Corporation 362

Event Locations

82,320 (55.3%)
I 66,100 (44.4%)
NO INFORMATION 195 (0.1%)
NOT APPLICABLE 79 (0.1%)
OTHER 72 (0.0%)
HOSPITAL 8 (0.0%)
UNKNOWN 1 (0.0%)

Compare ZOLL MANUFACTURING CORPORATION vs ZOLL LIFECOR CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Wearable Automated External Defibrillator: 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 (148,775 here).

Implantable Pulse Generator, Pacemaker 156,369 Ventricular Bypass 157,431 Prosthesis 157,471 Prosthesis, Hip, Semi-Constrained 138,399

Similar death-typed counts

Nearest other device types by death-typed report count (3,738 here), distinct from the volume row.

Pulse Generator, Permanent, Implantable 3,912 System, Peritoneal, Automatic Delivery 3,434 Permanent Defibrillator Electrodes 3,081 Automated External Defibrillators 4,510

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

Disclaimer: MAUDE figures for Wearable Automated External Defibrillator 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 Wearable Automated External Defibrillator; 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.