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2026 data FDA MAUDE openFDA FDA Class II

Electrode, Electrocardiograph

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 §870.2360 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Electrode, Electrocardiograph LIGHT-BOOK · MAUDE

#551 of 1000 · 1,587 reports · 1992–2026

  • BOOK 1,587 reports
  • RANK #551 of 1000
  • DEATH 23 death-typed
  • INJ 906 injury-typed
  • MALF 410 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 250
  • PHOTO Airway

Nearest event-volume peer: Airway, Oropharyngeal, Anesthesiology (1 report gap)

Electrode, Electrocardiograph sits #551 of 1000 among tracked device types with 1,587 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 →

Malfunction reports sit below the device-type norm

Electrode, Electrocardiograph carries 25.8% MALFUNCTION-coded reports, 39.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 57.1% corpus 30.3% · above corpus mean (+26.8 pp)
  • MALF 25.8% corpus 64.8% · below corpus mean (-39.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 24% of coded problems · Lead manufacturer COVIDIEN accounts for 68% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Electrode, Electrocardiograph in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Electrode, Electrocardiograph carries 1,587 MAUDE reports, ranked #551 of 1000.

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

Event Types

Injury 906 (57.1%)
Malfunction 410 (25.8%)
Other 133 (8.4%)
113 (7.1%)
Death 23 (1.4%)
No answer provided 2 (0.1%)

Patient Outcomes

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

Other 719 (42.6%)
422 (25.0%)
Required Intervention 240 (14.2%)
Hospitalization 146 (8.6%)
R 56 (3.3%)
H 35 (2.1%)
Death 28 (1.7%)
Life Threatening 17 (1.0%)
Disability 11 (0.7%)
O 8 (0.5%)
L 3 (0.2%)
S 3 (0.2%)
D 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 297
Insufficient Device Problem Information 245
Biocompatibility 196
Unknown (for use when the device problem is not known) 106
Patient-Device Incompatibility 89
Connection Problem 41
Device Operates Differently Than Expected 38
Use of Device Problem 30
Reaction 27
Improper or Incorrect Procedure or Method 23
Failure to Sense 20
Electrode(s), failure of 16
No Apparent Adverse Event 16
Patient Device Interaction Problem 16
Human-Device Interface Problem 15
Appropriate Device Problem Term/Code Not Available 14
Device Sensing Problem 14
Material Separation 13
Replace 13
Fitting Problem 12

Yearly Trend

92
1992: 5
93
1993: 1
94
1994: 12
95
1995: 7
96
1996: 22
97
1997: 27
98
1998: 15
99
1999: 10
00
2000: 10
01
2001: 18
02
2002: 12
03
2003: 12
04
2004: 11
05
2005: 14
06
2006: 17
07
2007: 47
08
2008: 15
09
2009: 36
10
2010: 48
11
2011: 80
12
2012: 41
13
2013: 70
14
2014: 27
15
2015: 58
16
2016: 37
17
2017: 55
18
2018: 43
19
2019: 50
20
2020: 53
21
2021: 55
22
2022: 61
23
2023: 113
24
2024: 61
25
2025: 250
26
2026: 194

Reports rose to 250 in 2025, up from an average of 87 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Electrode, Electrocardiograph

Top Manufacturers

COVIDIEN 107
PHYSIO-CONTROL, INC. - 3015876 50

Event Locations

864 (54.4%)
HOSPITAL 263 (16.6%)
I 225 (14.2%)
OTHER 133 (8.4%)
NO INFORMATION 52 (3.3%)
HOME 19 (1.2%)
INVALID DATA 10 (0.6%)
OUTPATIENT TREATMENT FACILITY 6 (0.4%)
UNKNOWN 5 (0.3%)
0 4 (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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Electrode, Electrocardiograph: 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 (1,587 here).

Airway, Oropharyngeal, Anesthesiology 1,588 Enzyme Linked Immunoabsorbent Assay 1,578 Tube 1,573 Table, Operating-Room, Electrical 1,602

Similar death-typed counts

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

Cannula, Catheter 23 Gastrointestinal Tubes With Enteral Specifi… 23 Regulator, Pressure, Gas Cylinder 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.