Devices › Computer, diagnostic, programmable
Device brand name · Computer diagnostic programmable
Carto 3 System: medical device reports filed with FDA
996 reports name it, 2010–2026. Manufacturer given most often on reports: Biosense Webster. Product code DQK.
- 996
- device reports naming the brand
- 0% of all MAUDE reports · about 61 a year
- 23
- reports, 12 months to August 2026
- 46 in the 12 months before
- 91.7%
- classified as malfunction
- 84.6% across the product code
- 0.8%
- classified as death, as reported
- 8 reports · not verified by FDA
996 medical device reports received by FDA name the brand "Carto 3 System" (computer diagnostic programmable); the manufacturer given most often on reports is Biosense Webster; received from February 2010 to June 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
23 reports arrived in the 12 months to August 2026, down 50% from 46 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 (91.7%), injury (7.3%) and death (0.8%); across all computer, diagnostic, programmable reports (product code DQK) death is recorded in 1.2% and malfunction in 84.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are display or visual feedback problem (23.1%), device displays incorrect message (11.9%) and signal artifact/noise (9%). The patient problems coded most often are cardiac tamponade, low blood pressure/ hypotension and ventricular tachycardia. 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 4,492 reports carrying product code DQK. 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 |
|---|---|---|---|
| Display or visual feedback problem | 230 | 23.1% | 10% |
| Device displays incorrect message | 119 | 11.9% | 4.6% |
| Signal artifact/noise | 90 | 9% | 5% |
| Image orientation incorrect | 81 | 8.1% | 1.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 80 | 8% | 3.3% |
| Pacing problem | 60 | 6% | 2.2% |
| Communication or transmission problemthe device could not communicate or transmit | 47 | 4.7% | 13.8% |
| Electromagnetic interference | 44 | 4.4% | 1.8% |
| No display/image | 44 | 4.4% | 3.4% |
| Noise, audible | 44 | 4.4% | 1.8% |
| Device alarm system | 35 | 3.5% | 0.8% |
| Computer operating system problem | 25 | 2.5% | 1.5% |
| Incorrect measurementthe device measured wrongly | 22 | 2.2% | 6% |
| Patient device interaction problem | 22 | 2.2% | 0.7% |
| Poor quality image | 22 | 2.2% | 1% |
| Application program problem | 19 | 1.9% | 2.9% |
| Electrical /electronic property probleman electrical or electronic problem | 19 | 1.9% | 0.8% |
| Image display error/artifact | 16 | 1.6% | 1% |
| Positioning problem | 16 | 1.6% | 0.5% |
| Device emits odor | 11 | 1.1% | 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 tamponade | 15 | 1.5% |
| Low blood pressure/ hypotension | 12 | 1.2% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 8 | 0.8% |
| Arrhythmia | 7 | 0.7% |
| Atrial fibrillationan irregular heart rhythm | 7 | 0.7% |
| Cardiac arrestthe heart stopped | 7 | 0.7% |
| Deaththe patient died; cause not stated by this term | 7 | 0.7% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 7 | 0.7% |
| Electric shockan electric shock | 4 | 0.4% |
| Pleural effusionfluid around the lung | 4 | 0.4% |
| Complete heart block | 3 | 0.3% |
| Pericardial effusionfluid around the heart | 3 | 0.3% |
| Cardiac perforation | 2 | 0.2% |
| No patient involvement | 2 | 0.2% |
| Painpain, site not specified | 2 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Carto 3 System | Product code DQK | All MAUDE reports |
|---|---|---|---|
| Reports | 996 | 4,492 | 26,136,888 |
| Share of that pool | — | 22.2% | 0% |
| Classified as death, per 1,000 reports | 8 | 12 | 9 |
| Classified as injury | 7.3% | 13.7% | 36.2% |
| Classified as malfunction | 91.7% | 84.6% | 62.3% |
| Filed by the manufacturer | 99.6% | 94.1% | 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 DQK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Merge Hemodynamics | 325 | 0 | 0% |
| Merge Hemo | 187 | 0 | 1.1% |
| iLab Ultrasound Imaging System | 1,075 | 85 | 0.2% |
| Affera | 1,159 | 992 | 2.1% |
| Advisor HD Grid Mapping Catheter, Sensor Enabled | 480 | 32 | 3.3% |
| Acist | 348 | 14 | 10.6% |
| Ampere RF Ablation Generator | 177 | 14 | 1.1% |
| Carescape | 4,902 | 2,289 | 0.1% |
| Dorado Pta Dilatation Catheter | 203 | 0 | 0% |
| Zio Monitor | 358 | 221 | 0% |
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 Carto 3 System reports
How many FDA reports name Carto 3 System?
996 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 23 in the latest 12 months.
What kinds of events are reported?
malfunction (91.7%), injury (7.3%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
display or visual feedback problem (23.1%), device displays incorrect message (11.9%), signal artifact/noise (9%), image orientation incorrect (8.1%) and device operates differently than expected (8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Carto 3 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.