Devices › Negative pressure wound therapy powered suction pump
Device brand name · Accessory to omp
V A C Therapy System: medical device reports filed with FDA
364 reports name it, 2006–2021. Manufacturer given most often on reports: Kci USA. Product code OMP.
- 364
- device reports naming the brand
- 0% of all MAUDE reports · about 18 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 4.7%
- classified as malfunction
- 63.1% across the product code
- 2.7%
- classified as death, as reported
- 10 reports · not verified by FDA
FDA's MAUDE database holds 364 reports that name the brand "V A C Therapy System" (accessory to omp), received between August 2006 and June 2021; the manufacturer given most often on reports is Kci USA. 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 injury (91.8%), malfunction (4.7%) and death (2.7%); 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 detachment of device component (20.1%), insufficient device problem information (15.9%) and improper or incorrect procedure or method (14.8%). The patient problems coded most often are surgical procedure, foreign body, removal of and hemorrhage/blood loss/bleeding. 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 V A C Therapy System was received in the five years to August 2026; the latest was received in June 2021.
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 |
|---|---|---|---|
| Detachment of device component | 73 | 20.1% | 0.8% |
| Insufficient device problem information | 58 | 15.9% | 9.8% |
| Improper or incorrect procedure or method | 54 | 14.8% | 3.3% |
| Difficult to removethe device was hard to remove | 39 | 10.7% | 0.5% |
| Device, removal of (non-implant) | 31 | 8.5% | 0.1% |
| Entrapment of device | 10 | 2.7% | 0.2% |
| Low audible alarm | 10 | 2.7% | 0.1% |
| Battery problema problem with the battery | 9 | 2.5% | 0.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 9 | 2.5% | 1.6% |
| No audible alarm | 8 | 2.2% | 0.7% |
| Sticking | 8 | 2.2% | 0.1% |
| Disconnection | 7 | 1.9% | 0.1% |
| Material fragmentation | 7 | 1.9% | 0.1% |
| Foreign material | 5 | 1.4% | 0% |
| Replace | 5 | 1.4% | 0% |
| Breakthe device broke | 4 | 1.1% | 0.5% |
| Leak/splashthe device leaked | 4 | 1.1% | 2% |
| Sparking | 4 | 1.1% | 0.2% |
| Suction problem | 4 | 1.1% | 1.9% |
| Device contamination with chemical or other material | 3 | 0.8% | 0.2% |
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 |
|---|---|---|
| Surgical procedure | 49 | 13.5% |
| Foreign body, removal of | 44 | 12.1% |
| Hemorrhage/blood loss/bleeding | 39 | 10.7% |
| Hospitalization required | 37 | 10.2% |
| Tissue damage | 31 | 8.5% |
| Impaired healingslow healing | 27 | 7.4% |
| Therapy/non-surgical treatment, additional | 25 | 6.9% |
| Fluid discharge | 19 | 5.2% |
| Treatment with medication(s) | 17 | 4.7% |
| Bleeding | 16 | 4.4% |
| Foreign body in patientpart of a device left in the patient | 14 | 3.8% |
| Painpain, site not specified | 13 | 3.6% |
| Abscessa collection of pus | 11 | 3% |
| Deaththe patient died; cause not stated by this term | 11 | 3% |
| Device embedded in tissue or plaque | 11 | 3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | V A C Therapy System | Product code OMP | All MAUDE reports |
|---|---|---|---|
| Reports | 364 | 9,182 | 26,136,888 |
| Share of that pool | — | 4% | 0% |
| Classified as death, per 1,000 reports | 27 | 8 | 9 |
| Classified as injury | 91.8% | 35.7% | 36.2% |
| Classified as malfunction | 4.7% | 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% |
| Activ A C Therapy System | 1,299 | 1 | 0.7% |
| 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 | 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 V A C Therapy System reports
How many FDA reports name V A C Therapy System?
364 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?
injury (91.8%), malfunction (4.7%) and death (2.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device component (20.1%), insufficient device problem information (15.9%), improper or incorrect procedure or method (14.8%), difficult to remove (10.7%) and device, removal of (non-implant) (8.5%). 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 V 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.