Device manufacturer, as written on reports

Cardiac Science: medical device reports filed with FDA

7,694 reports name it as the manufacturer of the device involved, 2001–2026.

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.

7,694
reports naming it as manufacturer: 0% of all MAUDE reports; 680
reports, 12 months to August 2026: 922 in the 12 months before; 98%
classified as malfunction: 62.3% across all reports; 1.6%
classified as death, as reported: 0.9% across all reports

7,694 medical device reports received by FDA give Cardiac Science as the manufacturer of the device involved, 0% of the MAUDE database, from December 2001 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

680 reports arrived in the 12 months to August 2026, down 26% from 922 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 (98%), death (1.6%) and injury (0.2%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Powerheart G5 Kit Semi Uk	Automated external defibrillators (non-wearable)	764	79	0.8%
G3 Plus Auto Aed Aha 2010 Us English	Automated external defibrillators (non-wearable)	679	17	0.1%
Powerheart G5 Kit Auto Us En/La Esp	Automated external defibrillators (non-wearable)	494	39	1.2%
Powerheart G5 Kit Auto Us Eng/Esp La	Automated external defibrillators (non-wearable)	346	91	0.6%
Powerheart G5 Kit Auto Uk	Automated external defibrillators (non-wearable)	344	30	0%
Powerheart G5 Kit Auto Us En/La Esp Cprd	Automated external defibrillators (non-wearable)	304	51	0.7%
G3 Plus Aed Aha 2010 English	Automated external defibrillators (non-wearable)	295	7	0%
Powerheart G5 Kit Auto Dut-Intl Eng Cprd	Automated external defibrillators (non-wearable)	294	3	0.3%
Powerheart G5 Kit Auto Uk Cprd	Automated external defibrillators (non-wearable)	236	16	0.4%
G3 Plus Auto Aed English Pkg	Automated external defibrillators (non-wearable)	166	12	1.2%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
MKJ	Automated external defibrillators (non-wearable)	7,645	99.4%
DPS	Electrocardiograph	13	0.2%
LDD	Dc-defibrillator, low-energy, (including paddles)	9	0.1%
MLN	Electrode, electrocardiograph, multi-function	3	0%
DRT	Monitor, cardiac (incl. cardiotachometer & rate alarm)	2	0%
DSI	Detector and alarm, arrhythmia	2	0%
CBK	Ventilator, continuous, facility use	1	0%

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

Death1.6%121

Injury0.2%19

Malfunction98%7,538

Other0.1%9

Not given0.1%7

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Cardiac Science reports

How many FDA device reports name Cardiac Science as manufacturer?

7,694 reports through August 2026, 680 of them in the latest 12 months.

Which of its brands appear most often?

Powerheart G5 Kit Semi Uk (764), G3 Plus Auto Aed Aha 2010 Us English (679), Powerheart G5 Kit Auto Us En/La Esp (494), Powerheart G5 Kit Auto Us Eng/Esp La (346) and Powerheart G5 Kit Auto Uk (344).

Which device types does it report on?

automated external defibrillators (non-wearable) (99.4%), electrocardiograph (0.2%), dc-defibrillator, low-energy, (including paddles) (0.1%) and electrode, electrocardiograph, multi-function (0%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.