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2026 data FDA MAUDE openFDA FDA Class II

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 §870.2340 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Electrocardiograph LIGHT-BOOK · MAUDE

#704 of 1000 · 868 reports · 1992–2026

  • BOOK 868 reports
  • RANK #704 of 1000
  • DEATH 35 death-typed
  • INJ 73 injury-typed
  • MALF 727 malfunction
  • SPAN 1992–2026
  • PEAK 2011: 121
  • PHOTO Instrument

Nearest event-volume peer: Instrument, Surgical, Disposable (2 report gap)

Electrocardiograph sits #704 of 1000 among tracked device types with 868 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 →

Injury-coded reports sit below the device-type norm

Electrocardiograph carries 8.4% INJURY-coded reports, 21.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.0% corpus 1.5% · above corpus mean (+2.5 pp)
  • INJ 8.4% corpus 30.3% · below corpus mean (-21.9 pp)
  • MALF 83.8% corpus 64.8% · above corpus mean (+18.9 pp)

Lead product-problem code Wireless Communication Problem is 15% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 42% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Electrocardiograph in the event-volume neighbourhood

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

reports

What this shows Electrocardiograph carries 868 MAUDE reports, ranked #704 of 1000.

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

Event Types

Malfunction 727 (83.8%)
Injury 73 (8.4%)
Death 35 (4.0%)
Other 17 (2.0%)
16 (1.8%)

Patient Outcomes

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

566 (64.8%)
Other 201 (23.0%)
Death 37 (4.2%)
Required Intervention 23 (2.6%)
Hospitalization 13 (1.5%)
Life Threatening 13 (1.5%)
O 5 (0.6%)
R 5 (0.6%)
L 3 (0.3%)
Invalid Data 3 (0.3%)
S 2 (0.2%)
Disability 2 (0.2%)

Top Product Problems

Wireless Communication Problem 100
Appropriate Device Problem Term/Code Not Available 74
Patient Data Problem 54
Fire 35
Incorrect Measurement 35
Data Problem 30
Intermittent Communication Failure 30
Device Operates Differently Than Expected 29
Incorrect, Inadequate or Imprecise Result or Readings 29
High Readings 28
Sparking 27
Incorrect Interpretation of Signal 25
Device Alarm System 23
Signal Artifact/Noise 22
Unable to Obtain Readings 21
Computer Software Problem 19
Display or Visual Feedback Problem 17
No Display/Image 17
Device Displays Incorrect Message 16
Improper or Incorrect Procedure or Method 15

Yearly Trend

92
1992: 5
93
1993: 4
94
1994: 3
95
1995: 1
96
1996: 2
97
1997: 2
98
1998: 7
99
1999: 19
00
2000: 12
01
2001: 8
02
2002: 5
03
2003: 5
04
2004: 13
05
2005: 5
06
2006: 8
07
2007: 9
08
2008: 17
09
2009: 14
10
2010: 21
11
2011: 121
12
2012: 56
13
2013: 15
14
2014: 15
15
2015: 30
16
2016: 12
17
2017: 15
18
2018: 19
19
2019: 27
20
2020: 59
21
2021: 24
22
2022: 59
23
2023: 54
24
2024: 64
25
2025: 57
26
2026: 81

Reports in 2025 (57) held close to the prior two-year average of 59.

Related Entities for Electrocardiograph

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 127
MEDTRONIC, INC. 115
ZOLL MEDICAL CORPORATION 30
PHILIPS NORTH AMERICA LLC 19
PHILIPS HEALTHCARE 13

Event Locations

473 (54.5%)
HOSPITAL 231 (26.6%)
I 121 (13.9%)
NO INFORMATION 13 (1.5%)
HOME 11 (1.3%)
UNKNOWN 7 (0.8%)
INVALID DATA 3 (0.3%)
OTHER 3 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.3%)
OUTPATIENT TREATMENT FACILITY 2 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)

Compare PHILIPS MEDICAL SYSTEMS vs MEDTRONIC, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for 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 (868 here).

Instrument, Surgical, Disposable 866 Clamp, Circumcision 862 Stent, Renal 874 Susceptibility Test Powders 874

Similar death-typed counts

Nearest other device types by death-typed report count (35 here), distinct from the volume row.

Adhesive 35 Balloon Aortic Valvuloplasty 35 Fluid Jet Removal System 35 Mattress, Flotation Therapy, Non-Powered 35

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.