Devices › Compressor, cardiac, external
Device brand name · Cardiac resuscitator line-powered
AutoPulse NXT Resuscitation System: medical device reports filed with FDA
192 reports name it, 2024–2026. Manufacturer given most often on reports: Zoll Circulation. Product code DRM.
- 192
- device reports naming the brand
- 0% of all MAUDE reports · about 92 a year
- 113
- reports, 12 months to August 2026
- 70 in the 12 months before
- 97.9%
- classified as malfunction
- 95.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
192 medical device reports received by FDA name the brand "AutoPulse NXT Resuscitation System" (cardiac resuscitator line-powered); the manufacturer given most often on reports is Zoll Circulation; received from June 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
113 reports arrived in the 12 months to August 2026, up 61% from 70 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 (97.9%) and injury (2.1%); 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 visual prompts will not clear (30.7%), device emits odor (13.5%) and overheating of device (8.9%). The patient problems coded most often are skin tears, abrasion and burn(s). 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 | 59 | 30.7% | 40.6% |
| Device emits odor | 26 | 13.5% | 0.3% |
| Overheating of device | 17 | 8.9% | 0.2% |
| Noise, audible | 13 | 6.8% | 0.9% |
| Unexpected shutdown | 12 | 6.3% | 1.3% |
| Failure to power up | 7 | 3.6% | 3.5% |
| Connection problema connection problem | 4 | 2.1% | 0.4% |
| Display or visual feedback problem | 4 | 2.1% | 1.5% |
| Retraction problem | 4 | 2.1% | 0.5% |
| Output problem | 3 | 1.6% | 0.3% |
| Temperature problem | 3 | 1.6% | 0% |
| Incorrect, inadequate or imprecise result or readings | 2 | 1% | 0% |
| Audible prompt/feedback problem | 1 | 0.5% | 0% |
| Battery problema problem with the battery | 1 | 0.5% | 5.2% |
| Failure to align | 1 | 0.5% | 0.1% |
| Failure to eject | 1 | 0.5% | 0% |
| Fumes or vapors | 1 | 0.5% | 0% |
| Intermittent loss of power | 1 | 0.5% | 0.1% |
| Key or button unresponsive/not working | 1 | 0.5% | 0.7% |
| Mechanical problema mechanical problem | 1 | 0.5% | 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 |
|---|---|---|
| Skin tears | 2 | 1% |
| Abrasion | 1 | 0.5% |
| Burn(s)a burn | 1 | 0.5% |
| Pulmonary embolisma blood clot in the lung | 1 | 0.5% |
| Skin erosion | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | AutoPulse NXT Resuscitation System | Product code DRM | All MAUDE reports |
|---|---|---|---|
| Reports | 192 | 11,439 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 18 | 9 |
| Classified as injury | 2.1% | 2.1% | 36.2% |
| Classified as malfunction | 97.9% | 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% |
| 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 NXT Resuscitation System reports
How many FDA reports name AutoPulse NXT Resuscitation System?
192 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 113 in the latest 12 months.
What kinds of events are reported?
malfunction (97.9%) and injury (2.1%). "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 (30.7%), device emits odor (13.5%), overheating of device (8.9%), noise, audible (6.8%) and unexpected shutdown (6.3%). 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 NXT 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.