Reported Reactions

Devices › Compressor, cardiac, external

Device brand name · Compressor cardiac external

Lucas 3 Chest Compression System: medical device reports filed with FDA

216 reports name it, 2023–2026. Manufacturer given most often on reports: Jolife - 3005445717. Product code DRM.

216
device reports naming the brand
0% of all MAUDE reports · about 62 a year
185
reports, 12 months to August 2026
10 in the 12 months before
87%
classified as malfunction
95.8% across the product code
5.1%
classified as death, as reported
11 reports · not verified by FDA

216 medical device reports received by FDA name the brand "Lucas 3 Chest Compression System" (compressor cardiac external); the manufacturer given most often on reports is Jolife - 3005445717; received from January 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

185 reports arrived in the 12 months to August 2026, up 1750% from 10 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 (87%), injury (7.9%) and death (5.1%); 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 (52.3%), key or button unresponsive/not working (19.9%) and mechanical jam (8.3%). The patient problems coded most often are skin tears, liver laceration(s) and aneurysm. 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

02652Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 4Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 1Jul 2023: 2Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 1Dec 2023: 02024Jan 2024: 1Feb 2024: 4Mar 2024: 0Apr 2024: 2May 2024: 4Jun 2024: 0Jul 2024: 1Aug 2024: 1Sep 2024: 0Oct 2024: 0Nov 2024: 1Dec 2024: 22025Jan 2025: 1Feb 2025: 0Mar 2025: 1Apr 2025: 0May 2025: 1Jun 2025: 2Jul 2025: 2Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 6Dec 2025: 262026Jan 2026: 14Feb 2026: 18Mar 2026: 12Apr 2026: 11May 2026: 13Jun 2026: 14Jul 2026: 19Aug 2026: 52

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.

By year received

0771532023: 820232024: 1620242025: 3920252026: 1532026

Event type and report source

Event type, as classified on the report

Death5.1%11
Injury7.9%17
Malfunction87%188
Other0%0
Not given0%0

Who filed the report

Manufacturer report94.4%204
Voluntary report0%0
User facility report0%0
Distributor report5.1%11
Not given0.5%1

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)ReportsShareShare across product code
Electrical /electronic property probleman electrical or electronic problem11352.3%3%
Key or button unresponsive/not working4319.9%0.7%
Mechanical jam188.3%0.6%
Detachment of device or device componentpart of the device came off62.8%0.2%
Mechanical problema mechanical problem62.8%0.7%
Sharp edges41.9%0%
Failure to power up31.4%3.5%
Device alarm system20.9%0.3%
Fire20.9%0.1%
Intermittent loss of power20.9%0.1%
Unexpected shutdown20.9%1.3%
Operating system becomes nonfunctional10.5%0%
Power problem10.5%0.4%

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)ReportsShare
Skin tears52.3%
Liver laceration(s)31.4%
Aneurysm10.5%
Bone fracture(s)10.5%
Cardiac arrestthe heart stopped10.5%
Hemorrhage/blood loss/bleeding10.5%
Spinal column injury10.5%

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

In context

MeasureLucas 3 Chest Compression SystemProduct code DRMAll MAUDE reports
Reports21611,43926,136,888
Share of that pool—1.9%0%
Classified as death, per 1,000 reports51189
Classified as injury7.9%2.1%36.2%
Classified as malfunction87%95.8%62.3%
Filed by the manufacturer94.4%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

BrandReportsLatest 12 monthsClassified as death
Autopulse Resuscitation Model 1003,77900%
Autopulse Platform Resuscitation1,85900%
Autopulse Resuscitation System Model 1001,56802.8%
AutoPulseResuscitation System9533340%
Autopulse Nimh Battery80703.6%
AutoPulse Li-ion Battery1,415270.1%
Autopulse Lifeband24600.4%
AutoPulse Resuscitation System232220.9%
AutoPulse NXT Resuscitation System1921130%
LUCAS 3 CPR Chest Compression System1581581.3%
Lifeline4,8772,1170.4%
Zoll221014%

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 Chest Compression System reports

How many FDA reports name Lucas 3 Chest Compression System?

216 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 185 in the latest 12 months.

What kinds of events are reported?

malfunction (87%), injury (7.9%) and death (5.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

electrical /electronic property problem (52.3%), key or button unresponsive/not working (19.9%), mechanical jam (8.3%), detachment of device or device component (2.8%) and mechanical problem (2.8%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (94.4%) and distributor reports (5.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Lucas 3 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.