Reported Reactions

Devices › Compressor, cardiac, external

Device brand name · Cardiac chest compressor

Autopulse Resuscitation System Model 100: medical device reports filed with FDA

1,568 reports name it, 2012–2016. Manufacturer given most often on reports: Zoll Circulation. Product code DRM.

1,568
device reports naming the brand
0% of all MAUDE reports · about 112 a year
0
reports, 12 months to August 2026
0 in the 12 months before
96%
classified as malfunction
95.8% across the product code
2.8%
classified as death, as reported
44 reports · not verified by FDA

FDA's MAUDE database holds 1,568 reports that name the brand "Autopulse Resuscitation System Model 100" (cardiac chest compressor), received between July 2012 and November 2016; the manufacturer given most often on reports is Zoll Circulation. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and 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%), death (2.8%) and injury (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 device displays incorrect message (62.9%), device operates differently than expected (13.9%) and visual prompts will not clear (7.4%). The patient problems coded most often are no patient involvement, death and cardiac arrest. 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

No report naming Autopulse Resuscitation System Model 100 was received in the five years to August 2026; the latest was received in November 2016.

By year received

03236452012: 19120122013: 64520132014: 45420142015: 22520152016: 532016

Event type and report source

Event type, as classified on the report

Death2.8%44
Injury1%16
Malfunction96%1,505
Other0.1%2
Not given0.1%1

Who filed the report

Manufacturer report100%1,568
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)ReportsShareShare across product code
Device displays incorrect message98762.9%21.6%
Device operates differently than expectedthe device behaved unexpectedly21813.9%9.1%
Visual prompts will not clear1167.4%40.6%
Device inoperablethe device could not be used815.2%1.7%
Failure to power up674.3%3.5%
Loss of powerthe device lost power583.7%1%
Battery problema problem with the battery563.6%5.2%
Breakthe device broke543.4%1.5%
Device stops intermittentlythe device stopped now and then352.2%1.4%
No display/image271.7%1.9%
Application interface becomes non-functional or program exits abnormally211.3%0.4%
Premature discharge of battery191.2%1%
Crackthe device cracked171.1%0.2%
Component missing161%0.2%
Sticking161%0.2%
Device alarm system151%0.3%
Loose or intermittent connection151%0.3%
Noise, audible130.8%0.9%
Retraction problem110.7%0.5%
Image display error/artifact100.6%0.1%

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
No patient involvement33721.5%
Deaththe patient died; cause not stated by this term1107%
Cardiac arrestthe heart stopped523.3%
Bone fracture(s)70.4%
Loss of consciousnesspassing out60.4%
Hemorrhage/blood loss/bleeding40.3%
Respiratory distressdifficulty breathing40.3%
Chest painchest pain30.2%
Injurya physical injury30.2%
Respiratory failurethe lungs could not supply enough oxygen30.2%
Abdominal distention20.1%
Complaint, ill-defined20.1%
Dyspneashortness of breath20.1%
Falla fall20.1%
Loss of pulse20.1%

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

In context

MeasureAutopulse Resuscitation System Model 100Product code DRMAll MAUDE reports
Reports1,56811,43926,136,888
Share of that pool—13.7%0%
Classified as death, per 1,000 reports28189
Classified as injury1%2.1%36.2%
Classified as malfunction96%95.8%62.3%
Filed by the manufacturer100%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%
AutoPulseResuscitation System9533340%
Autopulse Nimh Battery80703.6%
AutoPulse Li-ion Battery1,415270.1%
Autopulse Lifeband24600.4%
AutoPulse Resuscitation System232220.9%
Lucas 3 Chest Compression System2161855.1%
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 Autopulse Resuscitation System Model 100 reports

How many FDA reports name Autopulse Resuscitation System Model 100?

1,568 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (96%), death (2.8%) and injury (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device displays incorrect message (62.9%), device operates differently than expected (13.9%), visual prompts will not clear (7.4%), device inoperable (5.2%) and failure to power up (4.3%). 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 Autopulse Resuscitation System Model 100 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.