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2026 data FDA MAUDE openFDA FDA Class II

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.

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 LIGHT-BOOK · MAUDE

#594 of 1000 · 1,347 reports · 1994–2026

  • BOOK 1,347 reports
  • RANK #594 of 1000
  • DEATH 194 death-typed
  • INJ 109 injury-typed
  • MALF 943 malfunction
  • SPAN 1994–2026
  • PEAK 2000: 113
  • PHOTO Light Adjustable Lens…

Nearest event-volume peer: Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) (7 report gap)

Electrode, Electrocardiograph, Multi-Function sits #594 of 1000 among tracked device types with 1,347 MAUDE reports spanning 1994–2026. 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 →

Injury-coded reports sit below the device-type norm

Electrode carries 8.1% INJURY-coded reports, 22.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 14.4% corpus 1.5% · above corpus mean (+12.9 pp)
  • INJ 8.1% corpus 30.3% · below corpus mean (-22.2 pp)
  • MALF 70.0% corpus 64.8% · above corpus mean (+5.2 pp)

Lead product-problem code Replace 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 1,347 MAUDE reports, ranked #594 of 1000.

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

Event Types

Malfunction 943 (70.0%)
Death 194 (14.4%)
Injury 109 (8.1%)
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 (52.0%)
Other 338 (24.5%)
Death 209 (15.1%)
Required Intervention 42 (3.0%)
Life Threatening 28 (2.0%)
R 18 (1.3%)
Hospitalization 11 (0.8%)
O 9 (0.7%)
L 3 (0.2%)
S 3 (0.2%)
Disability 2 (0.1%)

Top Product Problems

Replace 223
Device Displays Incorrect Message 119
Arcing of Electrodes 117
Device Operates Differently Than Expected 68
Sparking 63
Unknown (for use when the device problem is not known) 58
Defibrillation/Stimulation Problem 57
Failure to Discharge 57
Failure To Adhere Or Bond 51
Thermal Decomposition of Device 43
Electrode(s), failure of 37
Arcing 35
Other (for use when an appropriate device code cannot be identified) 35
Reaction 33
Insufficient Device Problem Information 30
Connection Problem 29
Arcing at Paddles 28
Pacing Problem 27
Fire 25
Failure to Capture 24

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
26
2026: 2

Reports fell to 2 in 2025, down from an average of 5 in the two years before.

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

732 (54.3%)
HOSPITAL 377 (28.0%)
I 77 (5.7%)
OUTPATIENT TREATMENT FACILITY 38 (2.8%)
OTHER 33 (2.4%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Electrode: 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 (1,347 here).

Light Adjustable Lens And Light Delivery De… 1,354 Implant 1,332 Intrauterine Tamponade Balloon 1,328 Agent, Occluding, Vascular, Permanent 1,325

Similar death-typed counts

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

Prosthesis 195 System, Monitoring, Perinatal 195 Stimulator, Spinal-Cord, Implanted 196 Defibrillator, Implantable, Dual-Chamber 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.