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2026 data FDA MAUDE openFDA

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 · 143,491 reports · 2002–2026

  • BOOK 143,491 reports
  • RANK #29 of 1000
  • DEATH 3,639 death-typed
  • INJ 34,722 injury-typed
  • MALF 105,119 malfunction
  • SPAN 2002–2026
  • PEAK 2023: 12,988
  • PHOTO Integrated Continuous…

Nearest event-volume peer: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (3,446 report gap)

Wearable Automated External Defibrillator sits #29 of 1000 among tracked device types with 143,491 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 →

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 2.5% corpus 1.5% · above corpus mean (+1.0 pp)
  • INJ 24.2% corpus 30.4% · below corpus mean (-6.2 pp)
  • MALF 73.3% corpus 64.5% · above corpus mean (+8.8 pp)

Lead product-problem code Battery Problem is 13% of coded problems · Lead manufacturer ZOLL MANUFACTURING CORPORATION accounts for 90% of manufacturer-tagged reports · Top event location is 54% 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 143,491 MAUDE reports, ranked #29 of 1000.

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

Event Types

Malfunction 105,119 (73.3%)
Injury 34,722 (24.2%)
Death 3,639 (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.

115,313 (74.0%)
Other 12,179 (7.8%)
Hospitalization 7,354 (4.7%)
O 6,156 (4.0%)
R 5,765 (3.7%)
Required Intervention 4,501 (2.9%)
Death 3,850 (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 14,064
Inappropriate/Inadequate Shock/Stimulation 11,607
Failure to Power Up 11,042
Device Displays Incorrect Message 8,981
Adverse Event Without Identified Device or Use Problem 7,107
Circuit Failure 6,445
Patient Device Interaction Problem 5,513
Break 5,336
Signal Artifact/Noise 4,829
Charging Problem 3,889
Incorrect Interpretation of Signal 3,353
Key or Button Unresponsive/not Working 3,272
Patient-Device Incompatibility 3,128
Failure to Charge 3,071
Over-Sensing 3,049
Protective Measures Problem 3,012
Structural Problem 2,805
Contamination /Decontamination Problem 2,564
Device Operates Differently Than Expected 2,419
Failure of Device to Self-Test 2,330

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: 1,996

Related Entities for Wearable Automated External Defibrillator

Top Manufacturers

ZOLL MANUFACTURING CORPORATION 127,275
ZOLL LIFECOR CORPORATION 13,683

Event Locations

77,034 (53.7%)
I 66,102 (46.1%)
NO INFORMATION 195 (0.1%)
NOT APPLICABLE 79 (0.1%)
OTHER 72 (0.1%)
HOSPITAL 8 (0.0%)
UNKNOWN 1 (0.0%)

Compare ZOLL MANUFACTURING CORPORATION vs ZOLL LIFECOR CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Wearable Automated External Defibrillator, 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 (143,491 here).

Integrated Continuous Glucose Monitoring Sy… 146,937 Implantable Pulse Generator, Pacemaker 147,576 Prosthesis, Hip, Semi-Constrained 137,622 Ventricular Bypass 153,365

Similar death-typed counts

Nearest other device types by death-typed report count (3,639 here), distinct from the volume row.

Pulse Generator, Permanent, Implantable 3,860 System, Peritoneal, Automatic Delivery 3,401 Permanent Defibrillator Electrodes 3,030 Stimulator 2,889

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.