Outpatient Cardiac Telemetry
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 Outpatient Cardiac Telemetry LIGHT-BOOK · MAUDE
#807 of 1000 · 638 reports · 2023–2026
- BOOK 638 reports
- RANK #807 of 1000
- DEATH 13 death-typed
- INJ 76 injury-typed
- MALF 549 malfunction
- SPAN 2023–2026
- PEAK 2024: 400
- PHOTO Elevator
Nearest event-volume peer: Elevator, Surgical, Dental (0 report gap)
Outpatient Cardiac Telemetry sits #807 of 1000 among tracked device types with 638 MAUDE reports spanning 2023–2026. 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 → · Similar-volume device →
Malfunction reports run above the device-type norm
Outpatient Cardiac Telemetry carries 86.1% MALFUNCTION-coded reports, 21.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.0% corpus 1.5% · above corpus mean (+0.5 pp)
- INJ 11.9% corpus 30.3% · below corpus mean (-18.4 pp)
- MALF 86.1% corpus 64.8% · above corpus mean (+21.2 pp)
Lead product-problem code Failure to Transmit Record is 84% of coded problems · Top event location is 100% of location-tagged rows .
Outpatient Cardiac Telemetry in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Outpatient Ca… (this)
Outpatient Cardiac Telemetry
638 reports
- Elevator
Elevator, Surgical, Dental
638 reports
- Table
Table, Cystometric, Non-Electric And Accessories
638 reports
- Instrument
Instrument, Ligature Passing And Knot Tying
635 reports
- Polymer Patie…
Polymer Patient Examination Glove
635 reports
- Table
Table, Surgical With Orthopedic Accessories, Ac-Powered
632 reports
What this shows Outpatient Cardiac Telemetry carries 638 MAUDE reports, ranked #807 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 110 in 2025, down from an average of 237 in the two years before.
Related Entities for Outpatient Cardiac Telemetry
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Outpatient Cardiac Telemetry: 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 (638 here).
Similar death-typed counts
Nearest other device types by death-typed report count (13 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Outpatient Cardiac Telemetry 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 Outpatient Cardiac Telemetry; 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.