What are FDA adverse event reports for Electrocardiograph?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Electrocardiograph, there are 788 total reports including 33 death reports and 67 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 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

Electrocardiograph

Name: 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 Electrocardiograph LIGHT-BOOK · MAUDE

#723 of 1000 · 788 reports · 1992–2026

BOOK 788 reports
RANK #723 of 1000
DEATH 33 death-typed
INJ 67 injury-typed
MALF 655 malfunction
SPAN 1992–2026
PEAK 2011: 121
PHOTO Device

Nearest event-volume peer: Device, Fixation, Tracheal Tube (1 report gap)

Electrocardiograph sits #723 of 1000 among tracked device types with 788 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 4.2% corpus 1.5% · above corpus mean (+2.7 pp)
INJ 8.5% corpus 30.4% · below corpus mean (-21.9 pp)
MALF 83.1% corpus 64.5% · above corpus mean (+18.6 pp)

Lead product-problem code Wireless Communication Problem is 29% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 39% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Catheter

790
Electrode

790
Electrocardio… (this)

788
Device

787
Mesh

787
Scissors

786

What this shows Electrocardiograph carries 788 MAUDE reports, ranked #723 of 1000.

Event Types

Malfunction 655 (83.1%)

Injury 67 (8.5%)

Death 33 (4.2%)

Other 17 (2.2%)

16 (2.0%)

Patient Outcomes

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

505 (63.0%)

Other 197 (24.6%)

Death 34 (4.2%)

Required Intervention 23 (2.9%)

Life Threatening 13 (1.6%)

Hospitalization 10 (1.2%)

O 5 (0.6%)

R 5 (0.6%)

L 3 (0.4%)

Invalid Data 3 (0.4%)

S 2 (0.2%)

Disability 2 (0.2%)

Yearly Trend

1992: 5

1993: 4

1994: 3

1995: 1

1996: 2

1997: 2

1998: 7

1999: 19

2000: 12

2001: 8

2002: 5

2003: 5

2004: 13

2005: 5

2006: 8

2007: 9

2008: 17

2009: 14

2010: 21

2011: 121

2012: 56

2013: 15

2014: 15

2015: 30

2016: 12

2017: 15

2018: 19

2019: 27

2020: 59

2021: 24

2022: 59

2023: 54

2024: 64

2025: 57

2026: 1

Top Manufacturers

MEDTRONIC, INC. 115

PHILIPS MEDICAL SYSTEMS 104

ZOLL MEDICAL CORPORATION 30

PHILIPS NORTH AMERICA LLC 19

PHILIPS HEALTHCARE 13

PLEXUS MANUFACTURING SDN. BHD. 13

Event Locations

395 (50.1%)

HOSPITAL 229 (29.1%)

I 121 (15.4%)

NO INFORMATION 13 (1.6%)

HOME 11 (1.4%)

UNKNOWN 7 (0.9%)

INVALID DATA 3 (0.4%)

OTHER 3 (0.4%)

OUTPATIENT DIAGNOSTIC FACILITY 3 (0.4%)

OUTPATIENT TREATMENT FACILITY 2 (0.3%)

AMBULATORY SURGICAL FACILITY 1 (0.1%)

Compare MEDTRONIC, INC. vs PHILIPS MEDICAL SYSTEMS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for 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 (788 here).

Device, Fixation, Tracheal Tube 787 Mesh 787 Catheter, Nephrostomy 790 Electrode, Electrosurgical 790

Similar death-typed counts

Nearest other device types by death-typed report count (33 here), distinct from the volume row.

Bed, Air Fluidized 33 Catheter, Umbilical Artery 33 Glucose Dehydrogenase, Glucose 33 Percutaneously Delivered Prostheses And Tri… 33

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

Disclaimer: MAUDE figures for 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 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.

Electrocardiograph

Event-type mix vs corpus