Device brand name · Smartdrive
SmartDrive: medical device reports filed with FDA
932 reports name it, 2018–2026. Product code ITI.
- 932
- device reports naming the brand
- 0% of all MAUDE reports · about 110 a year
- 662
- reports, 12 months to August 2026
- 212 in the 12 months before
- 96.4%
- classified as malfunction
- 87.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
932 medical device reports received by FDA name the brand "SmartDrive" (smartdrive); received from January 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
662 reports arrived in the 12 months to August 2026, up 212% from 212 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 (96.4%) and injury (3.6%); across all wheelchair, powered reports (product code ITI) death is recorded in 0.6% and malfunction in 87.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are electrical /electronic property problem (97.5%), device remains activated (97.3%) and failure to shut off (97.3%). The patient problems coded most often are bone fracture(s), laceration(s) and bruise/contusion. 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 30,586 reports carrying product code ITI. 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 |
|---|---|---|---|
| Electrical /electronic property probleman electrical or electronic problem | 909 | 97.5% | 3.4% |
| Device remains activated | 907 | 97.3% | 3.3% |
| Failure to shut off | 907 | 97.3% | 4.6% |
| Complete loss of power | 2 | 0.2% | 0% |
| Mechanical problema mechanical problem | 2 | 0.2% | 6.6% |
| Power problem | 2 | 0.2% | 0.2% |
| Unintended power up | 2 | 0.2% | 0.1% |
| Activation problem | 1 | 0.1% | 0% |
| Activation, positioning or separation problem | 1 | 0.1% | 0% |
| Defective component | 1 | 0.1% | 0.2% |
| Difficult or delayed activation | 1 | 0.1% | 0.3% |
| Improper or incorrect procedure or method | 1 | 0.1% | 1% |
| Self-activation or keying | 1 | 0.1% | 2.2% |
| Sharp edges | 1 | 0.1% | 0% |
| Structural problem | 1 | 0.1% | 0% |
| Unintended movement | 1 | 0.1% | 2.8% |
| Unintended system motionthe device moved when it should not have | 1 | 0.1% | 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 |
|---|---|---|
| Bone fracture(s) | 17 | 1.8% |
| Laceration(s) | 12 | 1.3% |
| Bruise/contusion | 10 | 1.1% |
| Multiple fractures | 7 | 0.8% |
| Abrasion | 6 | 0.6% |
| Limb fracture | 4 | 0.4% |
| Limb pain | 4 | 0.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.2% |
| Concussionconcussion | 2 | 0.2% |
| Falla fall | 2 | 0.2% |
| Painpain, site not specified | 2 | 0.2% |
| Skin tears | 2 | 0.2% |
| Swelling/ edema | 2 | 0.2% |
| Anxietyanxiety | 1 | 0.1% |
| Balance problems | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | SmartDrive | Product code ITI | All MAUDE reports |
|---|---|---|---|
| Reports | 932 | 30,586 | 26,136,888 |
| Share of that pool | — | 3% | 0% |
| Classified as death, per 1,000 reports | 0 | 6 | 9 |
| Classified as injury | 3.6% | 9.8% | 36.2% |
| Classified as malfunction | 96.4% | 87.6% | 62.3% |
| Filed by the manufacturer | 99.4% | 98.7% | 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 ITI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Powered Wheelchair | 18,464 | 0 | 0.1% |
| Power Chair 20 Wide By 18 Deep For Pmi | 3,202 | 0 | 0% |
| Tdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear Box | 1,309 | 0 | 0.2% |
| Pride Mobility Products | 1,939 | 145 | 3.6% |
| M51p Blue Base W/Mk5 Nx Spj+ 9153642087 | 395 | 0 | 0% |
| Quickie | 1,619 | 1 | 0.2% |
| Tdxsp Wet Black Euro Narrow Base W/ 23-1 Ssd Gear Box | 270 | 0 | 0% |
| Invacare Power Wheelchair | 248 | 0 | 5.2% |
| Pride | 464 | 0 | 10.1% |
| Hoveround Corporation | 296 | 0 | 8.1% |
| Pronto M41 Blue Base 9153645762 | 185 | 0 | 0% |
| M51p Red Base W/Mk5 Nx Spj+ 9153642088 | 181 | 0 | 0% |
| Tdxsp Wet Black Euro Narrow Base W/ 18-1 Ssd Gear Box | 176 | 0 | 0% |
| Hoveround | 154 | 1 | 5.8% |
| Pronto M61 | 152 | 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 SmartDrive reports
How many FDA reports name SmartDrive?
932 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 662 in the latest 12 months.
What kinds of events are reported?
malfunction (96.4%) and injury (3.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
electrical /electronic property problem (97.5%), device remains activated (97.3%), failure to shut off (97.3%), complete loss of power (0.2%) and mechanical problem (0.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that SmartDrive 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.