Detector And Alarm, Arrhythmia
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 II (moderate risk, special controls required), regulated under 21 CFR §870.1025 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Detector And Alarm, Arrhythmia MID-BOOK · MAUDE
#101 of 1000 · 33,370 reports · 1992–2026
- BOOK 33,370 reports
- RANK #101 of 1000
- DEATH 505 death-typed
- INJ 2,612 injury-typed
- MALF 30,190 malfunction
- SPAN 1992–2026
- PEAK 2016: 4,352
- PHOTO Pump
Nearest event-volume peer: Pump, Infusion, Elastomeric (52 report gap)
Detector And Alarm, Arrhythmia sits #101 of 1000 among tracked device types with 33,370 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 →
Malfunction reports run above the device-type norm
Detector And Alarm, Arrhythmia carries 90.5% MALFUNCTION-coded reports, 25.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.5% corpus 1.5% · near corpus mean (+0.0 pp)
- INJ 7.8% corpus 30.3% · below corpus mean (-22.5 pp)
- MALF 90.5% corpus 64.8% · above corpus mean (+25.6 pp)
Lead product-problem code Under-Sensing is 22% of coded problems · Lead manufacturer MEDTRONIC EUROPE SARL accounts for 42% of manufacturer-tagged reports · Top event location I is 65% of location-tagged rows .
Detector And Alarm, Arrhythmia in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Wire
Wire, Guide, Catheter
33,688 reports
- Stents
Stents, Drains And Dilators For The Biliary Ducts
33,655 reports
- Pump
Pump, Infusion, Elastomeric
33,422 reports
- Detector And… (this)
Detector And Alarm, Arrhythmia
33,370 reports
- Pump
Pump, Infusion, Pca
32,663 reports
- Prosthesis
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
32,652 reports
What this shows Detector And Alarm, Arrhythmia carries 33,370 MAUDE reports, ranked #101 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 fell to 727 in 2025, down from an average of 1,469 in the two years before.
Related Entities for Detector And Alarm, Arrhythmia
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Detector And Alarm, Arrhythmia: 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 (33,370 here).
Similar death-typed counts
Nearest other device types by death-typed report count (505 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Detector And Alarm, Arrhythmia 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 Detector And Alarm, Arrhythmia; 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.