Automated external defibrillators (non-wearable): medical device reports filed with FDA

269,686 reports carry this product code, 1992–2026; 30 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.

269,686
reports with this product code: 1% of all MAUDE reports; 12,614
reports, 12 months to August 2026: 13,435 in the 12 months before; 96.8%
classified as malfunction: 62.3% across all reports; 1.7%
classified as death, as reported: 0.9% across all reports

Product code MKJ is FDA's classification for "Automated external defibrillators (non-wearable)" (cardiovascular panel), a class 3 device. 269,686 medical device reports carry this product code, 1% of the MAUDE database, from September 1992 to August 2026.

12,614 reports arrived in the 12 months to August 2026, close to the 13,435 of 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 (96.8%), death (1.7%) and injury (0.7%). 30 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	26,133	4	2.3%	97.4%
Heartstart Mrx	18,364	0	0.7%	98.5%
HeartStart MRx -EMS Defibrillator	16,151	33	0.8%	98.6%
Heart Start XL	15,937	95	0.9%	97.6%
R Series Defibrillator	14,893	0	0.9%	98.6%
X Series	13,669	1,692	2.7%	97.1%
HeartStart XL+ Defibrillator/Monitor	13,186	210	0.4%	98.4%
Heartstart Onsite	10,932	0	0.8%	99.1%
Aed Plus	9,221	423	2.2%	97.6%
Heartsine Samaritan 300p And Pad Pak	8,197	0	0.3%	84.9%
E Series Defibrillator	8,037	0	1.5%	98.4%
Lifepak R 15 Monitor/Defibrillator	6,117	463	1.4%	98.4%
Heartstart Frx	5,965	2	1.3%	98.4%
Efficia Dfm100	5,076	0	0.6%	95.5%
LIFEPAK 15 defibrillator/monitor	4,716	369	1%	98.7%
Lifeline	4,685	2,117	0.4%	98.9%
R Series	4,644	1,857	1%	97.9%
HeartStart MRx monitor/defib	3,776	107	0.5%	98.1%
LIFEPAK CR2 defibrillator	3,517	654	0.7%	99.3%
LIFEPAK(R) CR2 Defibrillator	3,476	528	0.7%	99.3%
Heartstart Mrx - Ems Defibrillator	2,645	0	2.3%	97%
Heartstream Fr2	2,587	0	6.6%	92.4%
Lifepak Cr R Plus Defibrillator	2,200	12	0.6%	99.3%
Aed Pro	1,923	94	3.6%	96.3%
Efficia Dfm100 Defibrillator/Monitor	1,703	0	0.4%	98.6%
Lifepak 12 Defibrillator/Monitor Series	1,692	0	4.9%	94.8%
Heartstart Xl	1,682	1	0.9%	98.1%
Heartstart Mrx-Ems Defibrillator	1,681	0	3.6%	96%
Lifepak Cr Plus Defibrillator	1,609	12	0.9%	99%
Lifepak R 12 Defibrillator/Monitor Series	1,587	0	1.5%	97.9%

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	88,450	32.8%
Zoll Medical	82,926	30.7%
Physio-Control - 3015876	22,028	8.2%
Philips North America	17,434	6.5%
Heartsine Technologies	12,335	4.6%
Physio-Control	11,975	4.4%
Cardiac Science	7,645	2.8%
Philips Goldway Shenzhen Industrial	7,149	2.7%
Defibtech	5,611	2.1%
Philips Healthcare	2,935	1.1%
Bio-Detek	1,685	0.6%
Welch Allyn Protocol	1,400	0.5%
Medtronic Physio-Control	669	0.2%
Medtronic Emergency Response Systems	506	0.2%
Agilent Technologies	442	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

Death1.7%4,528

Injury0.7%1,961

Malfunction96.8%261,107

Other0.2%571

Not given0.6%1,519

Who filed

Manufacturer report99.3%267,882

Voluntary report0.3%910

User facility report0%0

Distributor report0%9

Not given0.3%885

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

Device problems coded

Device problem (FDA code)	Reports	Share
Failure to power up	34,998	13%
Device operates differently than expectedthe device behaved unexpectedly	31,831	11.8%
Device displays incorrect message	31,217	11.6%
Failure of device to self-test	24,062	8.9%
Unable to obtain readings	11,879	4.4%
No display/image	11,373	4.2%
Defibrillation/stimulation problem	8,703	3.2%
Self-activation or keying	8,042	3%
Failure to charge	6,732	2.5%
Battery problema problem with the battery	6,718	2.5%
Device inoperablethe device could not be used	5,101	1.9%
Electrical /electronic property probleman electrical or electronic problem	4,996	1.9%
Unexpected shutdown	4,969	1.8%
Detachment of device or device componentpart of the device came off	4,910	1.8%
Failure to deliver shock/stimulation	4,910	1.8%
Failure to discharge	4,435	1.6%
Loss of powerthe device lost power	4,388	1.6%
Breakthe device broke	3,711	1.4%
Incorrect, inadequate or imprecise result or readings	3,447	1.3%
Pacing problem	3,157	1.2%

Questions about automated external defibrillators (non-wearable) reports

What is product code MKJ?

FDA's classification code for "Automated external defibrillators (non-wearable)", class 3, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

269,686 reports through August 2026, 12,614 of them in the latest 12 months.

Which brands appear most often?

M Series (26,133), Heartstart Mrx (18,364), HeartStart MRx -EMS Defibrillator (16,151), Heart Start XL (15,937) and R Series Defibrillator (14,893). 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.