Over-The-Counter Automated External Defibrillator
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).
FDA MAUDE casebook
openFDA event book Over-The-Counter Automated External Defibri… LIGHT-BOOK · MAUDE
#523 of 1000 · 1,803 reports · 2005–2026
- BOOK 1,803 reports
- RANK #523 of 1000
- DEATH 31 death-typed
- INJ 15 injury-typed
- MALF 1,756 malfunction
- SPAN 2005–2026
- PEAK 2025: 573
- PHOTO Operating Room Access…
Nearest event-volume peer: Operating Room Accessories Table Tray (1 report gap)
Over-The-Counter Automated External Defibrillator sits #523 of 1000 among tracked device types with 1,803 MAUDE reports spanning 2005–2026. 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
Over-The-Counter Automated External Defibri… carries 97.4% MALFUNCTION-coded reports, 32.6pp 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 0.8% corpus 30.3% · below corpus mean (-29.5 pp)
- MALF 97.4% corpus 64.8% · above corpus mean (+32.6 pp)
Lead product-problem code Failure of Device to Self-Test is 40% of coded problems · Lead manufacturer PHILIPS NORTH AMERICA LLC accounts for 47% of manufacturer-tagged reports · Top event location is 83% of location-tagged rows .
Over-The-Counter Automated External Defibri… in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Generator
Generator, Lesion, Radiofrequency
1,812 reports
- Stimulator
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
1,810 reports
- Over-The-Coun… (this)
Over-The-Counter Automated External Defibrillator
1,803 reports
- Operating Roo…
Operating Room Accessories Table Tray
1,802 reports
- Needle
Needle, Aspiration And Injection, Disposable
1,796 reports
- Prosthesis
Prosthesis, Elbow, Hemi-, Radial, Polymer
1,793 reports
What this shows Over-The-Counter Automated External Defibrillator carries 1,803 MAUDE reports, ranked #523 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 573 in 2025, up from an average of 80 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Over-The-Counter Automated External Defibrillator
Top Manufacturers
Event Locations
Compare PHILIPS NORTH AMERICA LLC vs PHILIPS MEDICAL SYSTEMS →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Over-The-Counter Automated External Defibri…: 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 (1,803 here).
Similar death-typed counts
Nearest other device types by death-typed report count (31 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Over-The-Counter Automated External Defibri… 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 Over-The-Counter Automated External Defibri…; 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.