Over-the-counter automated external defibrillator: medical device reports filed with FDA

1,854 reports carry this product code, 2005–2026; 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.

1,854
reports with this product code: 0% of all MAUDE reports; 782
reports, 12 months to August 2026: 244 in the 12 months before; 97.3%
classified as malfunction: 62.3% across all reports; 1.8%
classified as death, as reported: 0.9% across all reports

Product code NSA is FDA's classification for "Over-the-counter automated external defibrillator" (cardiovascular panel), a class 3 device. 1,854 medical device reports carry this product code, 0% of the MAUDE database, from December 2005 to August 2026.

782 reports arrived in the 12 months to August 2026, up 220% from 244 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 (97.3%), death (1.8%) and injury (0.9%). 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
HeartStart	858	837	1.4%	76.7%
Heartstart Home	660	0	1.3%	98.5%
Hs1+ W G Defib Japanese Exchg	6	0	0.7%	98.7%
Hs1 W B Onsite Defib Us English Exchg	5	4	1.5%	98.5%
Unknown Medical - Belfast Product	4	23	3.8%	96.3%
Heartstart Frx	1	2	1.3%	98.4%
Heartstart Onsite	1	0	0.8%	99.1%
Hs1 Defibrillator Japanese Exchange	1	0	0%	100%
Hs1 Onsite Defib Us English Exchange	1	0	0.8%	99%

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 North America	895	48.3%
Philips Medical Systems	655	35.3%
Heartsine Technologies	276	14.9%
Physio-Control - 3015876	10	0.5%

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

Death1.8%33

Injury0.9%16

Malfunction97.3%1,804

Other0%0

Not given0.1%1

Who filed

Manufacturer report99.9%1,853

Voluntary report0%0

User facility report0%0

Distributor report0.1%1

Not given0%0

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

Device problems coded

Device problem (FDA code)	Reports	Share
Failure of device to self-test	725	39.1%
Device operates differently than expectedthe device behaved unexpectedly	406	21.9%
Failure to power up	190	10.2%
No audible prompt/feedback	60	3.2%
Failure to run on battery	57	3.1%
Inaudible or unclear audible prompt/feedback	50	2.7%
Incorrect, inadequate or imprecise result or readings	39	2.1%
Inappropriate audible prompt/feedback	32	1.7%
Material split, cut or torn	32	1.7%
Electrical /electronic property probleman electrical or electronic problem	28	1.5%
Key or button unresponsive/not working	26	1.4%
Failure to deliver shock/stimulation	25	1.3%
Battery problema problem with the battery	24	1.3%
Audible prompt/feedback problem	17	0.9%
Device alarm system	16	0.9%
Premature discharge of battery	16	0.9%
Insufficient device problem information	13	0.7%
No visual prompts/feedback	13	0.7%
Device displays incorrect message	10	0.5%
Device sensing problem	10	0.5%

Questions about over-the-counter automated external defibrillator reports

What is product code NSA?

FDA's classification code for "Over-the-counter automated external defibrillator", class 3, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,854 reports through August 2026, 782 of them in the latest 12 months.

Which brands appear most often?

HeartStart (858), Heartstart Home (660), Hs1+ W G Defib Japanese Exchg (6), Hs1 W B Onsite Defib Us English Exchg (5) and Unknown Medical - Belfast Product (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.