Devices › System, image processing, radiological
Device brand name · Impax cv outbound report
Impax Cv Reporting: medical device reports filed with FDA
989 reports name it, 2012–2016. Manufacturer given most often on reports: Agfa Healthcare. Product code LLZ.
- 989
- device reports naming the brand
- 0% of all MAUDE reports · about 69 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.6%
- classified as malfunction
- 98.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 989 reports that name the brand "Impax Cv Reporting" (impax cv outbound report), received between February 2012 and December 2016; the manufacturer given most often on reports is Agfa Healthcare. 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 (99.6%) and other (0.4%); across all system, image processing, radiological reports (product code LLZ) death is recorded in 0.2% and malfunction in 98.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are nonstandard device (52%), patient data problem (50.2%) and communication or transmission problem (49.2%). The patient problems coded most often are misdiagnosis, mitral regurgitation and no patient involvement. 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 Impax Cv Reporting was received in the five years to August 2026; the latest was received in December 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 19,695 reports carrying product code LLZ. 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 |
|---|---|---|---|
| Nonstandard device | 514 | 52% | 75.2% |
| Patient data problem | 496 | 50.2% | 3.7% |
| Communication or transmission problemthe device could not communicate or transmit | 487 | 49.2% | 2.6% |
| Incorrect or inadequate test results | 164 | 16.6% | 1.6% |
| Improper or incorrect procedure or method | 162 | 16.4% | 1.2% |
| Insufficient device problem information | 116 | 11.7% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 106 | 10.7% | 2% |
| Failure to transmit record | 10 | 1% | 0.7% |
| Data problem | 8 | 0.8% | 1.2% |
| False device output | 6 | 0.6% | 0.1% |
| Incorrect measurementthe device measured wrongly | 6 | 0.6% | 0.8% |
| Display or visual feedback problem | 3 | 0.3% | 1% |
| Device displays incorrect message | 2 | 0.2% | 1% |
| Malposition of device | 2 | 0.2% | 0% |
| Occlusion within devicethe device blocked | 2 | 0.2% | 0.1% |
| Application program problem | 1 | 0.1% | 0.7% |
| Manufacturing, packaging or shipping problem | 1 | 0.1% | 0% |
| Operating system version or upgrade problem | 1 | 0.1% | 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) | Reports | Share |
|---|---|---|
| Misdiagnosis | 53 | 5.4% |
| Mitral regurgitation | 5 | 0.5% |
| No patient involvement | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Impax Cv Reporting | Product code LLZ | All MAUDE reports |
|---|---|---|---|
| Reports | 989 | 19,695 | 26,136,888 |
| Share of that pool | — | 5% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 0% | 0.6% | 36.2% |
| Classified as malfunction | 99.6% | 98.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 LLZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Impax Cv Outbound Results Management 2 08 | 13,239 | 0 | 0% |
| Impax Cv Outboung Results Management 2 08 | 1,582 | 0 | 0% |
| Impax Cv Outbound Results Mgmt 2 08 | 417 | 0 | 0% |
| IntelliSpace Cardiovascular | 393 | 393 | 0% |
| Entrak 2500 | 247 | 0 | 0% |
| Itrak 3500 | 235 | 0 | 0% |
| Merge Unity Pacs | 166 | 0 | 0.6% |
| Site~Rite 8 Ultrasound System | 312 | 112 | 0% |
| Visera Elite Video System Center | 2,688 | 572 | 0% |
| Guardian | 557 | 350 | 0.4% |
| VISERA Pro VIDEO SYSTEM CENTER | 637 | 96 | 0% |
| Emprint | 463 | 39 | 2.6% |
| Spectrum Infusion Pump | 147,363 | 15 | 0% |
| Tango Optimo | 158 | 0 | 0% |
| Pk Dissecting Forceps Instrument | 1,564 | 0 | 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 Impax Cv Reporting reports
How many FDA reports name Impax Cv Reporting?
989 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 (99.6%) and other (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
nonstandard device (52%), patient data problem (50.2%), communication or transmission problem (49.2%), incorrect or inadequate test results (16.6%) and improper or incorrect procedure or method (16.4%). 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 Impax Cv Reporting 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.