Devices › Compressor, cardiac, external
Device brand name · Cardiac resuscitator line-powered
AutoPulse Resuscitation System: medical device reports filed with FDA
232 reports name it, 2003–2026. Manufacturer given most often on reports: Zoll Circulation. Product code DRM.
- 232
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 22
- reports, 12 months to August 2026
- 24 in the 12 months before
- 90.5%
- classified as malfunction
- 95.8% across the product code
- 0.9%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 232 reports that name the brand "AutoPulse Resuscitation System" (cardiac resuscitator line-powered), received between February 2003 and August 2026; the manufacturer given most often on reports is Zoll Circulation. Spellings of one product vary from report to report.
22 reports arrived in the 12 months to August 2026, close to the 24 of 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 (90.5%), other (5.2%) and injury (3.4%); 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 visual prompts will not clear (38.4%), break (16.8%) and device displays incorrect message (11.2%). The patient problems coded most often are resuscitation, therapy/non-surgical treatment, additional and therapy/non-surgical treatment, aborted/stopped. 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.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
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 |
|---|---|---|---|
| Visual prompts will not clear | 89 | 38.4% | 40.6% |
| Breakthe device broke | 39 | 16.8% | 1.5% |
| Device displays incorrect message | 26 | 11.2% | 21.6% |
| Device issuea problem with the device | 12 | 5.2% | 0.8% |
| Unexpected shutdown | 6 | 2.6% | 1.3% |
| Component(s), broken | 5 | 2.2% | 0.1% |
| Other (for use when an appropriate device code cannot be identified) | 5 | 2.2% | 0.1% |
| Replace | 4 | 1.7% | 0.1% |
| Computer software problema software problem | 3 | 1.3% | 0% |
| Display or visual feedback problem | 3 | 1.3% | 1.5% |
| Fitting problem | 3 | 1.3% | 0.4% |
| Noise | 3 | 1.3% | 0% |
| Failure to power up | 2 | 0.9% | 3.5% |
| Malfunction | 2 | 0.9% | 0.1% |
| Material separation | 2 | 0.9% | 0.1% |
| Complete loss of power | 1 | 0.4% | 0.1% |
| Detachment of device component | 1 | 0.4% | 0.1% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.4% | 0% |
| Difficult to position | 1 | 0.4% | 0% |
| Display difficult to read | 1 | 0.4% | 0.8% |
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 |
|---|---|---|
| Resuscitation | 20 | 8.6% |
| Therapy/non-surgical treatment, additional | 14 | 6% |
| Therapy/non-surgical treatment, aborted/stopped | 10 | 4.3% |
| Deaththe patient died; cause not stated by this term | 7 | 3% |
| Manual ventilation required | 6 | 2.6% |
| No patient involvement | 6 | 2.6% |
| Hospitalization required | 4 | 1.7% |
| Bone fracture(s) | 2 | 0.9% |
| Loss of pulse | 2 | 0.9% |
| Other (for use when an appropriate patient code cannot be identified) | 2 | 0.9% |
| Abrasion | 1 | 0.4% |
| Asphyxia | 1 | 0.4% |
| Asystole | 1 | 0.4% |
| Cardiac arrestthe heart stopped | 1 | 0.4% |
| Chest painchest pain | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | AutoPulse Resuscitation System | Product code DRM | All MAUDE reports |
|---|---|---|---|
| Reports | 232 | 11,439 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 9 | 18 | 9 |
| Classified as injury | 3.4% | 2.1% | 36.2% |
| Classified as malfunction | 90.5% | 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% |
| Lucas 3 Chest Compression System | 216 | 185 | 5.1% |
| AutoPulse NXT Resuscitation System | 192 | 113 | 0% |
| LUCAS 3 CPR Chest Compression System | 158 | 158 | 1.3% |
| 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 AutoPulse Resuscitation System reports
How many FDA reports name AutoPulse Resuscitation System?
232 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 22 in the latest 12 months.
What kinds of events are reported?
malfunction (90.5%), other (5.2%) and injury (3.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
visual prompts will not clear (38.4%), break (16.8%), device displays incorrect message (11.2%), device issue (5.2%) and unexpected shutdown (2.6%). 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 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.