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2025 data FDA MAUDE openFDA

Electrode, Electrocardiograph, Multi-Function

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.

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FDA MAUDE casebook

openFDA event book Electrode LIGHT-BOOK · MAUDE

#581 of 1000 · 1,345 reports · 1994–2025

  • BOOK 1,345 reports
  • RANK #581 of 1000
  • DEATH 194 death-typed
  • INJ 107 injury-typed
  • MALF 943 malfunction
  • SPAN 1994–2025
  • PEAK 2000: 113
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Bone Growth, Non-Invasive (1 report gap)

Electrode, Electrocardiograph, Multi-Function sits #581 of 1000 among tracked device types with 1,345 MAUDE reports spanning 1994–2025. 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 14.4% corpus 1.5% · above corpus mean (+12.9 pp)
  • INJ 8.0% corpus 30.4% · below corpus mean (-22.5 pp)
  • MALF 70.1% corpus 64.5% · above corpus mean (+5.6 pp)

Lead product-problem code Device Operates Differently Than Expected is 19% of coded problems · Lead manufacturer ZOLL MEDICAL CORPORATION accounts for 42% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Electrode in the event-volume neighbourhood

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

reports

What this shows Electrode, Electrocardiograph, Multi-Function carries 1,345 MAUDE reports, ranked #581 of 1000.

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

Event Types

Malfunction 943 (70.1%)
Death 194 (14.4%)
Injury 107 (8.0%)
Other 86 (6.4%)
15 (1.1%)

Patient Outcomes

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

719 (52.1%)
Other 336 (24.4%)
Death 209 (15.2%)
Required Intervention 42 (3.0%)
Life Threatening 28 (2.0%)
R 17 (1.2%)
Hospitalization 11 (0.8%)
O 9 (0.7%)
L 3 (0.2%)
S 3 (0.2%)
Disability 2 (0.1%)

Top Product Problems

Device Operates Differently Than Expected 16
Failure of Device to Self-Test 9
Device Sensing Problem 7
Failure to Sense 7
Adverse Event Without Identified Device or Use Problem 6
Connection Problem 6
Appropriate Term/Code Not Available 4
Arcing of Electrodes 4
Insufficient Information 4
Failure to Deliver Shock/Stimulation 3
Sparking 3
Bent 2
Device Emits Odor 2
Failure to Discharge 2
Fire 2
Incomplete or Missing Packaging 2
Loose or Intermittent Connection 2
Break 1
Detachment of Device or Device Component 1
Device Stops Intermittently 1

Yearly Trend

94
1994: 2
95
1995: 2
96
1996: 39
97
1997: 82
98
1998: 70
99
1999: 54
00
2000: 113
01
2001: 95
02
2002: 55
03
2003: 57
04
2004: 45
05
2005: 60
06
2006: 32
07
2007: 35
08
2008: 77
09
2009: 91
10
2010: 67
11
2011: 46
12
2012: 34
13
2013: 81
14
2014: 60
15
2015: 57
16
2016: 20
17
2017: 19
18
2018: 14
19
2019: 11
20
2020: 1
21
2021: 7
22
2022: 8
23
2023: 8
24
2024: 1
25
2025: 2

Related Entities for Electrode, Electrocardiograph, Multi-Function

Top Manufacturers

ZOLL MEDICAL CORPORATION 337
ZOLL MEDICAL CORP. 216
COVIDIEN 91
PHILIPS MEDICAL SYSTEMS 61
ZOLL MEDICAL CORP 51
PHYSIO-CONTROL, INC 27
PHYSIO-CONTROL, INC. 27

Event Locations

730 (54.3%)
HOSPITAL 377 (28.0%)
I 77 (5.7%)
OUTPATIENT TREATMENT FACILITY 38 (2.8%)
OTHER 33 (2.5%)
UNKNOWN 31 (2.3%)
INVALID DATA 24 (1.8%)
HOME 17 (1.3%)
NO INFORMATION 10 (0.7%)
AMBULATORY SURGICAL FACILITY 3 (0.2%)
CLINIC - WALK IN, OTHER 1 (0.1%)
NOT APPLICABLE 1 (0.1%)
NURSING HOME 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
PUBLIC VENUE 1 (0.1%)

Compare ZOLL MEDICAL CORPORATION vs ZOLL MEDICAL CORP. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Electrode, 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 (1,345 here).

Stimulator, Bone Growth, Non-Invasive 1,344 Fluid Jet Removal System 1,331 Locator, Root Apex 1,381 Screw, Fixation, Bone, Non-Spinal, Metallic 1,382

Similar death-typed counts

Nearest other device types by death-typed report count (194 here), distinct from the volume row.

System, Monitoring, Perinatal 194 Stimulator, Spinal-Cord, Implanted 196 Defibrillator, Implantable, Dual-Chamber 191 Implant, Intragastric For Morbid Obesity 191

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

Disclaimer: MAUDE figures for Electrode 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; 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.