Monitor, cardiac (incl. cardiotachometer & rate alarm): medical device reports filed with FDA

3,115 reports carry this product code, 1992–2026; 24 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.

3,115
reports with this product code: 0% of all MAUDE reports; 66
reports, 12 months to August 2026: 22 in the 12 months before; 71.6%
classified as malfunction: 62.3% across all reports; 18.5%
classified as death, as reported: 0.9% across all reports

Product code DRT is FDA's classification for "Monitor, cardiac (incl. cardiotachometer & rate alarm)" (cardiovascular panel), a class 2 device. 3,115 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

66 reports arrived in the 12 months to August 2026, up 200% from 22 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 (71.6%), death (18.5%) and injury (5.7%). 24 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
R Series Defibrillator	359	0	0.9%	98.6%
X Series	268	1,692	2.7%	97.1%
Zm-531pa	170	38	1.1%	96.7%
Pic50	64	0	7%	93%
Panorama	53	0	4.5%	93.6%
Philips Information Center	33	0	70.7%	21.7%
Mrl	24	0	4.9%	93.6%
Delta	13	22	7.2%	63.9%
Datascope	8	0	7.3%	40.2%
Panorama Central Station	7	0	2.2%	94.3%
E Series Defibrillator	5	0	1.5%	98.4%
Dash	4	0	8.8%	73.6%
Philips	3	0	6.3%	78.9%
Aed Pro	2	94	3.6%	96.3%
Aed Plus	1	423	2.2%	97.6%
Cardiosave Hybrid Type B Plug	1	2,631	0.4%	99.3%
Engstrom	1	304	0.2%	99.3%
Hill-Rom	1	0	18.7%	31.1%
Infinity	1	24	2.1%	45.6%
Lifepak 11 Diagnostic Cardiac Monitor	1	0	2.4%	97.6%
Lifepak 9p Defibrillator/Monitor/Pacemaker	1	0	2.9%	95.5%
M Series	1	4	2.3%	97.4%
Pic 50	1	0	1.1%	98.6%
Spectrum	1	11	0.6%	83.4%

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
Zoll Medical	675	21.7%
Nihon Kohden	529	17%
Philips Medical Systems	218	7%
Agilent Technologies	143	4.6%
Ge Healthcare	132	4.2%
Welch Allyn Protocol	75	2.4%
Datascope	66	2.1%
Mindray Ds USA	62	2%
Welch Allyn	27	0.9%
Draeger Medical Systems	22	0.7%
Ge Medical Systems	18	0.6%
Philips Healthcare	17	0.5%
Spacelabs Healthcare	10	0.3%
Hill-Rom	6	0.2%
Respironics	5	0.2%

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

Death18.5%576

Injury5.7%177

Malfunction71.6%2,229

Other2.9%89

Not given1.4%44

Who filed

Manufacturer report82%2,555

Voluntary report6.9%214

User facility report0%0

Distributor report1.9%58

Not given9.2%288

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

Device problems coded

Device problem (FDA code)	Reports	Share
Unable to obtain readings	532	17.1%
Device alarm system	434	13.9%
No audible alarm	195	6.3%
Overheating of device	192	6.2%
Device displays incorrect message	186	6%
No display/image	154	4.9%
Temperature problem	147	4.7%
Output problem	133	4.3%
Incorrect, inadequate or imprecise result or readings	90	2.9%
Display or visual feedback problem	87	2.8%
Communication or transmission problemthe device could not communicate or transmit	81	2.6%
Device issuea problem with the device	76	2.4%
Device operates differently than expectedthe device behaved unexpectedly	75	2.4%
Loss of powerthe device lost power	68	2.2%
Self-activation or keying	62	2%
Monitor failure	60	1.9%
Other (for use when an appropriate device code cannot be identified)	53	1.7%
Alarm, failure of warning	46	1.5%
Replace	46	1.5%
Alarm, audible	37	1.2%

Questions about monitor, cardiac (incl. cardiotachometer & rate alarm) reports

What is product code DRT?

FDA's classification code for "Monitor, cardiac (incl. cardiotachometer & rate alarm)", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,115 reports through August 2026, 66 of them in the latest 12 months.

Which brands appear most often?

R Series Defibrillator (359), X Series (268), Zm-531pa (170), Pic50 (64) and Panorama (53). 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.