2026 data FDA MAUDE openFDA FDA Class II

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

reports

What this shows Outpatient Cardiac Telemetry carries 638 MAUDE reports, ranked #807 of 1000.

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

Event Types

Malfunction 549 (86.1%)
Injury 76 (11.9%)
Death 13 (2.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

536 (83.4%)
Required Intervention 64 (10.0%)
Death 17 (2.6%)
Other 8 (1.2%)
Hospitalization 7 (1.1%)
H 4 (0.6%)
Life Threatening 4 (0.6%)
L 1 (0.2%)
O 1 (0.2%)
Congenital Anomaly 1 (0.2%)

Top Product Problems

Failure to Transmit Record 539
Patient-Device Incompatibility 61
Adverse Event Without Identified Device or Use Problem 16
Inaccurate Information 11
Use of Device Problem 5
Patient Data Problem 3
Insufficient Device Problem Information 2
Communication or Transmission Problem 1
Fire 1
No Apparent Adverse Event 1
Unclear Information 1
Wireless Communication Problem 1

Yearly Trend

23
2023: 74
24
2024: 400
25
2025: 110
26
2026: 54

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

638 (100.0%)

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.

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.