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 MAUDE casebook
openFDA event book Over-The-Counter Automated External Defibri… LIGHT-BOOK · MAUDE
#547 of 1000 · 1,538 reports · 2005–2026
- BOOK 1,538 reports
- RANK #547 of 1000
- DEATH 28 death-typed
- INJ 10 injury-typed
- MALF 1,499 malfunction
- SPAN 2005–2026
- PEAK 2025: 573
- PHOTO Barrier
Nearest event-volume peer: Barrier, Absorbable, Adhesion (0 report gap)
Over-The-Counter Automated External Defibrillator sits #547 of 1000 among tracked device types with 1,538 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 →
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 1.8% corpus 1.5% · near corpus mean (+0.3 pp)
- INJ 0.7% corpus 30.4% · below corpus mean (-29.8 pp)
- MALF 97.5% corpus 64.5% · above corpus mean (+33.0 pp)
Lead product-problem code Failure of Device to Self-Test is 46% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 43% of manufacturer-tagged reports · Top event location is 80% 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
- Enzyme Linked…
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
1,544 reports
- Over-The-Coun… (this)
Over-The-Counter Automated External Defibrillator
1,538 reports
- Barrier
Barrier, Absorbable, Adhesion
1,538 reports
- Equipment
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
1,536 reports
- Catheter
Catheter, Umbilical Artery
1,535 reports
- Set
Set, Tubing And Support, Ventilator (W Harness)
1,531 reports
What this shows Over-The-Counter Automated External Defibrillator carries 1,538 MAUDE reports, ranked #547 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
Related Entities for Over-The-Counter Automated External Defibrillator
Top Manufacturers
Event Locations
Compare PHILIPS MEDICAL SYSTEMS vs PHILIPS NORTH AMERICA LLC →
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Over-The-Counter Automated External Defibri…, 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 (1,538 here).
Similar death-typed counts
Nearest other device types by death-typed report count (28 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.