Reported Reactions

Devices › Wheelchair, powered

Device brand name · Powered wheelchair product code iti

Powered Wheelchair: medical device reports filed with FDA

18,464 reports name it, 2008–2014. Manufacturer given most often on reports: Invacare Taylor Street. Product code ITI.

18,464
device reports naming the brand
0.1% of all MAUDE reports · about 1,041 a year
0
reports, 12 months to August 2026
0 in the 12 months before
96.8%
classified as malfunction
87.6% across the product code
0.1%
classified as death, as reported
17 reports · not verified by FDA

18,464 medical device reports received by FDA name the brand "Powered Wheelchair" (powered wheelchair product code iti); the manufacturer given most often on reports is Invacare Taylor Street; received from October 2008 to November 2014. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 (96.8%), injury (1.7%) and other (0.5%); 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 device operates differently than expected (21.5%), break (14%) and leak/splash (7%). The patient problems coded most often are injury, fall 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

No report naming Powered Wheelchair was received in the five years to August 2026; the latest was received in November 2014.

By year received

04,3138,6262008: 2420082009: 7520092010: 8220102011: 46220112012: 2,78620122013: 8,62620132014: 6,4092014

Event type and report source

Event type, as classified on the report

Death0.1%17
Injury1.7%322
Malfunction96.8%17,876
Other0.5%90
Not given0.9%159

Who filed the report

Manufacturer report100%18,463
Voluntary report0%0
User facility report0%0
Distributor report0%1
Not given0%0

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)ReportsShareShare across product code
Device operates differently than expectedthe device behaved unexpectedly3,96621.5%17.6%
Breakthe device broke2,58514%12.5%
Leak/splashthe device leaked1,2847%5.1%
Mechanical problema mechanical problem1,1356.1%6.6%
Device inoperablethe device could not be used7994.3%3.6%
Sticking7744.2%3.4%
Bent7073.8%3.4%
Device slipped6973.8%3.2%
Detachment of device component6353.4%3.1%
Device displays incorrect message6273.4%3%
Unintended system motionthe device moved when it should not have5973.2%3%
Loss of powerthe device lost power5863.2%3%
Device stops intermittentlythe device stopped now and then5453%2.8%
Unintended movement4242.3%2.8%
Nonstandard device4042.2%1.5%
Self-activation or keying3652%2.2%
Noise, audible3551.9%1.7%
Application interface becomes non-functional or program exits abnormally3431.9%1.2%
Crackthe device cracked2921.6%1.6%
Naturally worn2821.5%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)ReportsShare
Injurya physical injury3692%
Falla fall3111.7%
Bruise/contusion1340.7%
Bone fracture(s)1100.6%
Laceration(s)700.4%
Physical entrapment350.2%
Painpain, site not specified320.2%
Pressure sore/ulcer230.1%
Tooth fracture210.1%
Abrasion190.1%
Head injurya head injury190.1%
Deaththe patient died; cause not stated by this term180.1%
Swellingswelling180.1%
Discomfortdiscomfort150.1%
Tissue damage150.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasurePowered WheelchairProduct code ITIAll MAUDE reports
Reports18,46430,58626,136,888
Share of that pool—60.4%0.1%
Classified as death, per 1,000 reports169
Classified as injury1.7%9.8%36.2%
Classified as malfunction96.8%87.6%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Power Chair 20 Wide By 18 Deep For Pmi3,20200%
Tdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear Box1,30900.2%
Pride Mobility Products1,9391453.6%
SmartDrive9326620%
M51p Blue Base W/Mk5 Nx Spj+ 915364208739500%
Quickie1,61910.2%
Tdxsp Wet Black Euro Narrow Base W/ 23-1 Ssd Gear Box27000%
Invacare Power Wheelchair24805.2%
Pride464010.1%
Hoveround Corporation29608.1%
Pronto M41 Blue Base 915364576218500%
M51p Red Base W/Mk5 Nx Spj+ 915364208818100%
Tdxsp Wet Black Euro Narrow Base W/ 18-1 Ssd Gear Box17600%
Hoveround15415.8%
Pronto M6115200%

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 Powered Wheelchair reports

How many FDA reports name Powered Wheelchair?

18,464 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 (96.8%), injury (1.7%) and other (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device operates differently than expected (21.5%), break (14%), leak/splash (7%), mechanical problem (6.1%) and device inoperable (4.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%) and distributor reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Powered Wheelchair 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.