Electrode, electrocardiograph: medical device reports filed with FDA

1,611 reports carry this product code, 1992–2026; 9 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,611
reports with this product code: 0% of all MAUDE reports; 362
reports, 12 months to August 2026: 112 in the 12 months before; 25.5%
classified as malfunction: 62.3% across all reports; 1.5%
classified as death, as reported: 0.9% across all reports

Product code DRX is FDA's classification for "Electrode, electrocardiograph" (cardiovascular panel), a class 2 device. 1,611 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

362 reports arrived in the 12 months to August 2026, up 223% from 112 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (57.5%), malfunction (25.5%) and other (8.3%). 9 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Universal electrode-patch	188	160	0.5%	0.5%
Nissha Medical Technologies	177	144	0%	0%
Skintact	82	17	0.4%	24.5%
Kendall	32	23	2.3%	61.5%
TruWave Disposable Pressure Transducer	4	67	0.5%	96.5%
Conmed	1	89	0.2%	65.6%
Electrodes Onestep Complete	1	0	4.9%	89.8%
Electrodes Onestep Complete Single R Series	1	8	1.8%	90.3%
Valleylab	1	353	0.3%	81.8%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Conmed	232	14.4%
3m	69	4.3%
3m Health Care	64	4%
Vyaire Medical	58	3.6%
Physio-Control - 3015876	52	3.2%
Cardinal Health	24	1.5%
Cardinal Health 200	18	1.1%
Consolidated Medical Equipment	9	0.6%
Medtronic Physio-Control	7	0.4%
Zoll Medical	5	0.3%
Bio-Detek	4	0.2%
Medline Industries	3	0.2%
Conmed Electrosurgery	2	0.1%
Datex-Ohmeda	2	0.1%
Ge Medical Systems	2	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1.5%24

Injury57.5%927

Malfunction25.5%411

Other8.3%134

Not given7.1%115

Who filed

Manufacturer report68.3%1,101

Voluntary report10.3%166

User facility report0%0

Distributor report9.5%153

Not given11.9%191

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	246	15.3%
Biocompatibility	212	13.2%
Patient-device incompatibilitythe device did not suit the patient	88	5.5%
Connection problema connection problem	41	2.5%
Device operates differently than expectedthe device behaved unexpectedly	38	2.4%
Reactiona reaction, type not specified	26	1.6%
Improper or incorrect procedure or method	21	1.3%
Failure to sense	20	1.2%
Electrode(s), failure of	16	1%
Device sensing problem	15	0.9%
Patient device interaction problem	15	0.9%
Human-device interface problem	14	0.9%
Replace	13	0.8%
Fitting problem	12	0.7%
Detachment of device component	11	0.7%
Material separation	11	0.7%
Other (for use when an appropriate device code cannot be identified)	11	0.7%
Defective component	10	0.6%
Communication or transmission problemthe device could not communicate or transmit	9	0.6%
Disconnection	9	0.6%

Questions about electrode, electrocardiograph reports

What is product code DRX?

FDA's classification code for "Electrode, electrocardiograph", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,611 reports through August 2026, 362 of them in the latest 12 months.

Which brands appear most often?

Universal electrode-patch (188), Nissha Medical Technologies (177), Skintact (82), Kendall (32) and TruWave Disposable Pressure Transducer (4). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.