Devices › System, imaging, pulsed doppler, ultrasonic
Device brand name · System imaging pulsed doppler ultrasonic
Epiq Cvx: medical device reports filed with FDA
402 reports name it, 2020–2026. Manufacturer given most often on reports: Philips Ultrasound. Product code IYN.
- 402
- device reports naming the brand
- 0% of all MAUDE reports · about 70 a year
- 122
- reports, 12 months to August 2026
- 92 in the 12 months before
- 96.8%
- classified as malfunction
- 87.8% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
402 medical device reports received by FDA name the brand "Epiq Cvx" (system imaging pulsed doppler ultrasonic); the manufacturer given most often on reports is Philips Ultrasound; received from October 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
122 reports arrived in the 12 months to August 2026, up 33% from 92 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 (96.8%), injury (3%) and death (0.2%); across all system, imaging, pulsed doppler, ultrasonic reports (product code IYN) death is recorded in 1.3% and malfunction in 87.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unintended system motion (48%), application program freezes or fails to launch (11.4%) and mechanical jam (6.5%). The patient problems coded most often are gastroesophageal burn, discomfort and electric shock. 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 2,691 reports carrying product code IYN. 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 |
|---|---|---|---|
| Unintended system motionthe device moved when it should not have | 193 | 48% | 19.5% |
| Application program freezes or fails to launch | 46 | 11.4% | 5.5% |
| Mechanical jam | 26 | 6.5% | 2.9% |
| Material integrity problema problem with the device material | 18 | 4.5% | 5.1% |
| Unintended application program shut down | 18 | 4.5% | 2.1% |
| Electrical /electronic property probleman electrical or electronic problem | 12 | 3% | 3.4% |
| Material split, cut or torn | 10 | 2.5% | 1.6% |
| Unexpected shutdown | 10 | 2.5% | 1.7% |
| No device output | 6 | 1.5% | 1% |
| No display/image | 5 | 1.2% | 3% |
| Crackthe device cracked | 4 | 1% | 0.9% |
| Material separation | 4 | 1% | 1.6% |
| Operating system becomes nonfunctional | 4 | 1% | 0.7% |
| Overheating of device | 4 | 1% | 0.4% |
| Poor quality image | 4 | 1% | 3.1% |
| Degraded | 3 | 0.7% | 0.1% |
| Detachment of device or device componentpart of the device came off | 3 | 0.7% | 1.5% |
| Image display error/artifact | 3 | 0.7% | 0.5% |
| Breakthe device broke | 2 | 0.5% | 1.7% |
| Patient data problem | 2 | 0.5% | 2.5% |
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 |
|---|---|---|
| Gastroesophageal burn | 3 | 0.7% |
| Discomfortdiscomfort | 2 | 0.5% |
| Electric shockan electric shock | 2 | 0.5% |
| Perforation of esophagus | 2 | 0.5% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| Laceration(s) | 1 | 0.2% |
| Perforation | 1 | 0.2% |
| Stroke/cva | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Epiq Cvx | Product code IYN | All MAUDE reports |
|---|---|---|---|
| Reports | 402 | 2,691 | 26,136,888 |
| Share of that pool | — | 14.9% | 0% |
| Classified as death, per 1,000 reports | 2 | 13 | 9 |
| Classified as injury | 3% | 9.6% | 36.2% |
| Classified as malfunction | 96.8% | 87.8% | 62.3% |
| Filed by the manufacturer | 99.8% | 91.6% | 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 IYN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Epiq 7 | 273 | 71 | 1.1% |
| ACUSON SC2000 Ultrasound System | 221 | 11 | 0% |
| Acuson | 691 | 0 | 0.4% |
| Acuson Z6ms Ultrasound Transducer | 292 | 3 | 0% |
| HYDROS Robotic System | 164 | 125 | 3% |
| Toshiba | 158 | 0 | 1.9% |
| Philips | 190 | 0 | 6.3% |
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 Epiq Cvx reports
How many FDA reports name Epiq Cvx?
402 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 122 in the latest 12 months.
What kinds of events are reported?
malfunction (96.8%), injury (3%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unintended system motion (48%), application program freezes or fails to launch (11.4%), mechanical jam (6.5%), material integrity problem (4.5%) and unintended application program shut down (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Epiq Cvx 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.