Electrocardiograph: medical device reports filed with FDA

879 reports carry this product code, 1992–2026; 5 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.

879
reports with this product code: 0% of all MAUDE reports; 110
reports, 12 months to August 2026: 58 in the 12 months before; 83.8%
classified as malfunction: 62.3% across all reports; 4%
classified as death, as reported: 0.9% across all reports

Product code DPS is FDA's classification for "Electrocardiograph" (cardiovascular panel), a class 2 device. 879 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

110 reports arrived in the 12 months to August 2026, up 90% from 58 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 malfunction (83.8%), injury (8.4%) and death (4%). 5 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
M Series	31	4	2.3%	97.4%
Philips	4	0	6.3%	78.9%
Heartstart Fr3 Ecg Basic Bundle Japan	1	0	5.1%	93.7%
Impax Cv Outbound Results Management 2 08	1	0	0%	100%
Mrl	1	0	4.9%	93.6%

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
Philips Medical Systems	94	10.7%
Medtronic	82	9.3%
Philips Medizin Systeme B Blingen	33	3.8%
Zoll Medical	32	3.6%
Philips North America	20	2.3%
Medtronic Milaca	16	1.8%
Welch Allyn	14	1.6%
Cardiac Science	13	1.5%
Philips Healthcare	13	1.5%
Plexus Manufacturing Sdn Bhd	13	1.5%
Ge Healthcare	8	0.9%
Nihon Kohden	5	0.6%
Agilent Technologies	2	0.2%
Philips Goldway Shenzhen Industrial	2	0.2%
Agfa Healthcare	1	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

Death4%35

Injury8.4%74

Malfunction83.8%737

Other1.9%17

Not given1.8%16

Who filed

Manufacturer report79.2%696

Voluntary report8.4%74

User facility report0%0

Distributor report0%0

Not given12.4%109

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

Device problems coded

Device problem (FDA code)	Reports	Share
Wireless communication problema wireless connection problem	100	11.4%
Patient data problem	55	6.3%
Incorrect measurementthe device measured wrongly	38	4.3%
Fire	35	4%
Incorrect, inadequate or imprecise result or readings	32	3.6%
Data problem	30	3.4%
High readingsreadings were too high	30	3.4%
Device operates differently than expectedthe device behaved unexpectedly	29	3.3%
Intermittent communication failure	28	3.2%
Sparking	25	2.8%
Device alarm system	23	2.6%
Incorrect interpretation of signal	23	2.6%
Unable to obtain readings	20	2.3%
Computer software problema software problem	19	2.2%
Signal artifact/noise	19	2.2%
Display or visual feedback problem	17	1.9%
Device displays incorrect message	16	1.8%
Improper or incorrect procedure or method	14	1.6%
No display/image	14	1.6%
Breakthe device broke	13	1.5%

Questions about electrocardiograph reports

What is product code DPS?

FDA's classification code for "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?

879 reports through August 2026, 110 of them in the latest 12 months.

Which brands appear most often?

M Series (31), Philips (4), Heartstart Fr3 Ecg Basic Bundle Japan (1), Impax Cv Outbound Results Management 2 08 (1) and Mrl (1). 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.