Devices › Negative pressure wound therapy powered suction pump
Device brand name · Omp
Activ A C Therapy System: medical device reports filed with FDA
1,299 reports name it, 2017–2025. Manufacturer given most often on reports: Kinetic Concepts. Product code OMP.
- 1,299
- device reports naming the brand
- 0% of all MAUDE reports · about 137 a year
- 1
- reports, 12 months to August 2026
- 3 in the 12 months before
- 83.6%
- classified as malfunction
- 63.1% across the product code
- 0.7%
- classified as death, as reported
- 9 reports · not verified by FDA
1,299 medical device reports received by FDA name the brand "Activ A C Therapy System" (omp); the manufacturer given most often on reports is Kinetic Concepts; received from January 2017 to September 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1 reports arrived in the 12 months to August 2026, down 67% from 3 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 (83.6%), injury (15.7%) and death (0.7%); across all negative pressure wound therapy powered suction pump reports (product code OMP) death is recorded in 0.8% and malfunction in 63.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are collapse (81.3%), unexpected shutdown (11%) and insufficient device problem information (2.2%). The patient problems coded most often are no patient involvement, necrosis and tissue breakdown. 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 9,182 reports carrying product code OMP. 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 |
|---|---|---|---|
| Collapse | 1,056 | 81.3% | 12.5% |
| Unexpected shutdown | 143 | 11% | 2.4% |
| Insufficient device problem information | 28 | 2.2% | 9.8% |
| Pressure problem | 9 | 0.7% | 0.4% |
| Improper or incorrect procedure or method | 6 | 0.5% | 3.3% |
| Alarm not visible | 5 | 0.4% | 0.3% |
| No audible alarm | 5 | 0.4% | 0.7% |
| Smoking | 4 | 0.3% | 0.2% |
| Thermal decomposition of device | 4 | 0.3% | 0.3% |
| Decrease in pressure | 3 | 0.2% | 0.2% |
| Fire | 3 | 0.2% | 0.3% |
| Power problem | 3 | 0.2% | 0.3% |
| Suction failure | 3 | 0.2% | 7.3% |
| Circuit failure | 2 | 0.2% | 0.1% |
| Decrease in suction | 2 | 0.2% | 0.3% |
| Device alarm system | 2 | 0.2% | 4% |
| Device contamination with chemical or other material | 2 | 0.2% | 0.2% |
| Leak/splashthe device leaked | 2 | 0.2% | 2% |
| Overheating of device | 2 | 0.2% | 1.4% |
| Premature discharge of battery | 2 | 0.2% | 0% |
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 |
|---|---|---|
| No patient involvement | 166 | 12.8% |
| Necrosisdeath of tissue | 27 | 2.1% |
| Tissue breakdown | 25 | 1.9% |
| Hemorrhage/blood loss/bleeding | 24 | 1.8% |
| Tissue damage | 15 | 1.2% |
| Blood loss | 12 | 0.9% |
| Fungal infectiona fungal infection | 12 | 0.9% |
| Bacterial infectiona bacterial infection | 8 | 0.6% |
| Failure of implant | 8 | 0.6% |
| Impaired healingslow healing | 6 | 0.5% |
| Injurya physical injury | 5 | 0.4% |
| Painpain, site not specified | 3 | 0.2% |
| Abscessa collection of pus | 2 | 0.2% |
| Bone fracture(s) | 2 | 0.2% |
| Post operative wound infection | 2 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Activ A C Therapy System | Product code OMP | All MAUDE reports |
|---|---|---|---|
| Reports | 1,299 | 9,182 | 26,136,888 |
| Share of that pool | — | 14.1% | 0% |
| Classified as death, per 1,000 reports | 7 | 8 | 9 |
| Classified as injury | 15.7% | 35.7% | 36.2% |
| Classified as malfunction | 83.6% | 63.1% | 62.3% |
| Filed by the manufacturer | 100% | 97% | 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 OMP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Renasys Go | 1,324 | 0 | 0.2% |
| Unkn Pico | 459 | 0 | 0% |
| Renasys Touch Device & Power Sup | 447 | 0 | 0% |
| Activ A C Ion Progress Remote Therapy Monitoring System | 378 | 0 | 2.1% |
| Renasys Touch Non Connect 4th Ed Device | 358 | 0 | 0% |
| V A C Therapy System | 364 | 0 | 2.7% |
| V A C Therapy | 225 | 0 | 0.9% |
| Renasys Tch Device&power Sply | 220 | 0 | 0% |
| V A C Granufoam Dressing | 194 | 10 | 0% |
| Renasys Go Npwt Device | 201 | 0 | 0% |
| Unkn Opsite | 208 | 0 | 0% |
| Opsite Flexifix Gentle 5cmx5m | 206 | 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 Activ A C Therapy System reports
How many FDA reports name Activ A C Therapy System?
1,299 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.
What kinds of events are reported?
malfunction (83.6%), injury (15.7%) and death (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
collapse (81.3%), unexpected shutdown (11%), insufficient device problem information (2.2%), pressure problem (0.7%) and improper or incorrect procedure or method (0.5%). 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 Activ A C Therapy 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.