Device brand name · Compressor cardiac external

LUCAS 3 CPR Chest Compression System: medical device reports filed with FDA

158 reports name it, 2025–2026. Manufacturer given most often on reports: Jolife - 3005445717. Product code DRM.

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.

158
device reports naming the brand: 0% of all MAUDE reports · about 158 a year; 158
reports, 12 months to August 2026: 0 in the 12 months before; 96.2%
classified as malfunction: 95.8% across the product code; 1.3%
classified as death, as reported: 2 reports · not verified by FDA

158 medical device reports received by FDA name the brand "LUCAS 3 CPR Chest Compression System" (compressor cardiac external); the manufacturer given most often on reports is Jolife - 3005445717; received from October 2025 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

158 reports arrived in the 12 months to August 2026, with none 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 (96.2%), death (1.3%) and injury (1.3%); across all compressor, cardiac, external reports (product code DRM) death is recorded in 1.8% and malfunction in 95.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are electrical /electronic property problem (65.2%), key or button unresponsive/not working (19%) and mechanical jam (15.2%). The patient problems coded most often are cardiac arrest and perforation of vessels. 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."

Reports by month, five years

Reports by the month FDA received them. 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, as classified on the report

Death1.3%2

Injury1.3%2

Malfunction96.2%152

Other1.3%2

Not given0%0

Who filed the report

Manufacturer report100%158

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 11,439 reports carrying product code DRM. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Electrical /electronic property probleman electrical or electronic problem	103	65.2%	3%
Key or button unresponsive/not working	30	19%	0.7%
Mechanical jam	24	15.2%	0.6%
Detachment of device or device componentpart of the device came off	3	1.9%	0.2%
Device alarm system	2	1.3%	0.3%
Failure to power up	2	1.3%	3.5%
Mechanical problema mechanical problem	2	1.3%	0.7%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Cardiac arrestthe heart stopped	4	2.5%
Perforation of vessels	1	0.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	LUCAS 3 CPR Chest Compression System	Product code DRM	All MAUDE reports
Reports	158	11,439	26,136,888
Share of that pool	—	1.4%	0%
Classified as death, per 1,000 reports	13	18	9
Classified as injury	1.3%	2.1%	36.2%
Classified as malfunction	96.2%	95.8%	62.3%
Filed by the manufacturer	100%	98.3%	94.9%

Shares are of reports, not 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."

Other brands with product code DRM

Brand	Reports	Latest 12 months	Classified as death
Autopulse Resuscitation Model 100	3,779	0	0%
Autopulse Platform Resuscitation	1,859	0	0%
Autopulse Resuscitation System Model 100	1,568	0	2.8%
AutoPulseResuscitation System	953	334	0%
Autopulse Nimh Battery	807	0	3.6%
AutoPulse Li-ion Battery	1,415	27	0.1%
Autopulse Lifeband	246	0	0.4%
AutoPulse Resuscitation System	232	22	0.9%
Lucas 3 Chest Compression System	216	185	5.1%
AutoPulse NXT Resuscitation System	192	113	0%
Lifeline	4,877	2,117	0.4%
Zoll	221	0	14%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about LUCAS 3 CPR Chest Compression System reports

How many FDA reports name LUCAS 3 CPR Chest Compression System?

158 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 158 in the latest 12 months.

What kinds of events are reported?

malfunction (96.2%), death (1.3%) and injury (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

electrical /electronic property problem (65.2%), key or button unresponsive/not working (19%), mechanical jam (15.2%), detachment of device or device component (1.9%) and device alarm system (1.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that LUCAS 3 CPR Chest Compression System was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.