What are FDA adverse event reports for Electrode, Electrocardiograph?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Electrode, Electrocardiograph, there are 1,455 total reports including 23 death reports and 779 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 Electrode, Electrocardiograph?

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

Electrode, Electrocardiograph

Name: Electrode, Electrocardiograph - 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 Electrode, Electrocardiograph LIGHT-BOOK · MAUDE

#567 of 1000 · 1,455 reports · 1992–2026

BOOK 1,455 reports
RANK #567 of 1000
DEATH 23 death-typed
INJ 779 injury-typed
MALF 405 malfunction
SPAN 1992–2026
PEAK 2025: 250
PHOTO Patch

Nearest event-volume peer: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (8 report gap)

Electrode, Electrocardiograph sits #567 of 1000 among tracked device types with 1,455 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 →

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 1.6% corpus 1.5% · near corpus mean (+0.1 pp)
INJ 53.5% corpus 30.4% · above corpus mean (+23.1 pp)
MALF 27.8% corpus 64.5% · below corpus mean (-36.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 30% of coded problems · Lead manufacturer COVIDIEN accounts for 68% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Instrument

1,465
Radioimmunoas…

1,465
Lift

1,464
Patch

1,463
Electrode (this)

1,455
Prosthesis

1,446

What this shows Electrode, Electrocardiograph carries 1,455 MAUDE reports, ranked #567 of 1000.

Event Types

Injury 779 (53.5%)

Malfunction 405 (27.8%)

Other 133 (9.1%)

113 (7.8%)

Death 23 (1.6%)

No answer provided 2 (0.1%)

Patient Outcomes

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

Other 651 (42.1%)

418 (27.0%)

Required Intervention 233 (15.1%)

Hospitalization 95 (6.1%)

R 52 (3.4%)

H 33 (2.1%)

Death 28 (1.8%)

Life Threatening 15 (1.0%)

Disability 9 (0.6%)

O 7 (0.5%)

S 3 (0.2%)

D 1 (0.1%)

L 1 (0.1%)

Yearly Trend

1992: 5

1993: 1

1994: 12

1995: 7

1996: 22

1997: 27

1998: 15

1999: 10

2000: 10

2001: 18

2002: 12

2003: 12

2004: 11

2005: 14

2006: 17

2007: 47

2008: 15

2009: 36

2010: 48

2011: 80

2012: 41

2013: 70

2014: 27

2015: 58

2016: 37

2017: 55

2018: 43

2019: 50

2020: 53

2021: 55

2022: 61

2023: 113

2024: 61

2025: 250

2026: 62

Top Manufacturers

COVIDIEN 107

PHYSIO-CONTROL, INC. - 3015876 50

Event Locations

773 (53.1%)

HOSPITAL 261 (17.9%)

I 225 (15.5%)

OTHER 99 (6.8%)

NO INFORMATION 52 (3.6%)

HOME 18 (1.2%)

INVALID DATA 10 (0.7%)

OUTPATIENT TREATMENT FACILITY 6 (0.4%)

UNKNOWN 5 (0.3%)

OUTPATIENT DIAGNOSTIC FACILITY 4 (0.3%)

AMBULATORY SURGICAL FACILITY 1 (0.1%)

CLINIC - WALK IN, OTHER 1 (0.1%)

Compare COVIDIEN vs PHYSIO-CONTROL, INC. - 3015876 →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Electrode, Electrocardiograph, 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 (1,455 here).

Patch 1,463 Lift, Patient, Ac-Powered 1,464 Prosthesis 1,446 Instrument, Cutting, Orthopedic 1,465

Similar death-typed counts

Nearest other device types by death-typed report count (23 here), distinct from the volume row.

Cannula, Catheter 23 Regulator, Pressure, Gas Cylinder 23 Stylet For Catheter, Gastro-Urology 23 Transducer, Ultrasonic, Diagnostic 23

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Electrode, Electrocardiograph 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 Electrode, Electrocardiograph; 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.

Electrode, Electrocardiograph

Event-type mix vs corpus