What are FDA adverse event reports for Outpatient Cardiac Telemetry?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Outpatient Cardiac Telemetry, there are 605 total reports including 13 death reports and 69 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Outpatient Cardiac Telemetry?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Outpatient Cardiac Telemetry

Name: Outpatient Cardiac Telemetry - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Outpatient Cardiac Telemetry LIGHT-BOOK · MAUDE

#806 of 1000 · 605 reports · 2023–2026

BOOK 605 reports
RANK #806 of 1000
DEATH 13 death-typed
INJ 69 injury-typed
MALF 523 malfunction
SPAN 2023–2026
PEAK 2024: 400
PHOTO Rongeur

Nearest event-volume peer: Rongeur (1 report gap)

Outpatient Cardiac Telemetry sits #806 of 1000 among tracked device types with 605 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 →

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 2.1% corpus 1.5% · above corpus mean (+0.6 pp)
INJ 11.4% corpus 30.4% · below corpus mean (-19.0 pp)
MALF 86.4% corpus 64.5% · above corpus mean (+21.9 pp)

Lead product-problem code Failure to Transmit Record is 85% of coded problems · Top event location is 100% of location-tagged rows .

Outpatient Ca… (this)

605
Rongeur

604
Unit

604
Instrument

600
Source

599
Drill

598

What this shows Outpatient Cardiac Telemetry carries 605 MAUDE reports, ranked #806 of 1000.

Event Types

Malfunction 523 (86.4%)

Injury 69 (11.4%)

Death 13 (2.1%)

Patient Outcomes

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

515 (84.4%)

Required Intervention 52 (8.5%)

Death 17 (2.8%)

Other 8 (1.3%)

Hospitalization 7 (1.1%)

H 4 (0.7%)

Life Threatening 4 (0.7%)

L 1 (0.2%)

O 1 (0.2%)

Congenital Anomaly 1 (0.2%)

Yearly Trend

2023: 74

2024: 400

2025: 110

2026: 21

Event Locations

605 (100.0%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Outpatient Cardiac Telemetry, 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 (605 here).

Rongeur 604 Unit, Liquid-Oxygen, Portable 604 Instrument, Ligature Passing And Knot Tying 600 Source, Brachytherapy, Radionuclide 599

Similar death-typed counts

Nearest other device types by death-typed report count (13 here), distinct from the volume row.

Apparatus 13 Chair, With Casters 13 Continuous Measurement Thermometer 13 Immunoassay Method, Troponin Subunit 13

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.

Outpatient Cardiac Telemetry

Event-type mix vs corpus