Devices › Tourniquet, pneumatic
Device brand name · Tourniquet pneumatic
SmartPump Dual Channel: medical device reports filed with FDA
211 reports name it, 2009–2025. Manufacturer given most often on reports: Stryker Instruments-Kalamazoo. Product code KCY.
- 211
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 2
- reports, 12 months to August 2026
- 11 in the 12 months before
- 93.4%
- classified as malfunction
- 86.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 211 reports that name the brand "SmartPump Dual Channel" (tourniquet pneumatic), received between February 2009 and October 2025; the manufacturer given most often on reports is Stryker Instruments-Kalamazoo. Spellings of one product vary from report to report.
2 reports arrived in the 12 months to August 2026, down 82% from 11 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 (93.4%) and injury (6.6%); across all tourniquet, pneumatic reports (product code KCY) death is recorded in 0.1% and malfunction in 86.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are pressure problem (20.4%), decrease in pressure (12.3%) and leak/splash (8.1%). The patient problems coded most often are hemorrhage/blood loss/bleeding, blood loss 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
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 1,994 reports carrying product code KCY. 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 |
|---|---|---|---|
| Pressure problem | 43 | 20.4% | 11.2% |
| Decrease in pressure | 26 | 12.3% | 15.6% |
| Leak/splashthe device leaked | 17 | 8.1% | 17.5% |
| Increase in pressure | 11 | 5.2% | 2.1% |
| Deflation problem | 6 | 2.8% | 4.5% |
| Device inoperablethe device could not be used | 5 | 2.4% | 0.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 2.4% | 4.3% |
| Inflation problem | 4 | 1.9% | 5.7% |
| Loss of powerthe device lost power | 4 | 1.9% | 0.5% |
| No pressure | 4 | 1.9% | 0.7% |
| Device stops intermittentlythe device stopped now and then | 2 | 0.9% | 0.1% |
| Electrical /electronic property probleman electrical or electronic problem | 2 | 0.9% | 0.2% |
| Fluid/blood leak | 2 | 0.9% | 0.8% |
| Gas/air leak | 2 | 0.9% | 11.3% |
| Self-activation or keying | 2 | 0.9% | 0.5% |
| Smoking | 2 | 0.9% | 0.2% |
| Air leak | 1 | 0.5% | 6.1% |
| Battery problema problem with the battery | 1 | 0.5% | 0.4% |
| Breakthe device broke | 1 | 0.5% | 1.2% |
| Detachment of device component | 1 | 0.5% | 0.3% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 8 | 3.8% |
| Blood loss | 6 | 2.8% |
| No patient involvement | 6 | 2.8% |
| Painpain, site not specified | 5 | 2.4% |
| Bruise/contusion | 4 | 1.9% |
| Hospitalization required | 4 | 1.9% |
| Thrombosis | 4 | 1.9% |
| Treatment with medication(s) | 4 | 1.9% |
| Confusion/ disorientation | 1 | 0.5% |
| Edemaswelling from fluid | 1 | 0.5% |
| Erythemaskin redness | 1 | 0.5% |
| Swelling/ edema | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | SmartPump Dual Channel | Product code KCY | All MAUDE reports |
|---|---|---|---|
| Reports | 211 | 1,994 | 26,136,888 |
| Share of that pool | — | 10.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 6.6% | 11.6% | 36.2% |
| Classified as malfunction | 93.4% | 86.8% | 62.3% |
| Filed by the manufacturer | 100% | 89.3% | 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 KCY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Zimmer Skin Graft Mesher | 3,463 | 285 | 0% |
| Electric Dermatome Handpiece | 265 | 0 | 0% |
| Fan Spray Kit | 850 | 173 | 0% |
| Zimmer | 1,159 | 0 | 2.8% |
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 SmartPump Dual Channel reports
How many FDA reports name SmartPump Dual Channel?
211 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2 in the latest 12 months.
What kinds of events are reported?
malfunction (93.4%) and injury (6.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
pressure problem (20.4%), decrease in pressure (12.3%), leak/splash (8.1%), increase in pressure (5.2%) and deflation problem (2.8%). 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 SmartPump Dual Channel 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.