Reported Reactions

Devices › Wheelchair, powered

Device brand name · Wheelchair powered

M51p Blue Base W/Mk5 Nx Spj+ 9153642087: medical device reports filed with FDA

395 reports name it, 2014–2016. Manufacturer given most often on reports: Invacare Taylor Street. Product code ITI.

395
device reports naming the brand
0% of all MAUDE reports · about 34 a year
0
reports, 12 months to August 2026
0 in the 12 months before
97.7%
classified as malfunction
87.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

395 medical device reports received by FDA name the brand "M51p Blue Base W/Mk5 Nx Spj+ 9153642087" (wheelchair powered); the manufacturer given most often on reports is Invacare Taylor Street; received from December 2014 to December 2016. 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 (97.7%) and injury (2.3%); 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 (21.8%), mechanical problem (14.2%) and break (12.2%). The patient problems coded most often are fall, injury 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 M51p Blue Base W/Mk5 Nx Spj+ 9153642087 was received in the five years to August 2026; the latest was received in December 2016.

By year received

01252492014: 4620142015: 24920152016: 1002016

Event type and report source

Event type, as classified on the report

Death0%0
Injury2.3%9
Malfunction97.7%386
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%395
Voluntary report0%0
User facility report0%0
Distributor report0%0
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 unexpectedly8621.8%17.6%
Mechanical problema mechanical problem5614.2%6.6%
Breakthe device broke4812.2%12.5%
Device displays incorrect message256.3%3%
Leak/splashthe device leaked225.6%5.1%
Unintended movement215.3%2.8%
Device stops intermittentlythe device stopped now and then194.8%2.8%
Loss of powerthe device lost power194.8%3%
Device inoperablethe device could not be used174.3%3.6%
Device slipped133.3%3.2%
Detachment of device component102.5%3.1%
Failure to shut off102.5%4.6%
Self-activation or keying102.5%2.2%
Sticking102.5%3.4%
Noise, audible92.3%1.7%
Unintended collision82%1.2%
Battery problema problem with the battery71.8%0.8%
Bent61.5%3.4%
Loose or intermittent connection61.5%0.9%
Naturally worn61.5%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
Falla fall102.5%
Injurya physical injury102.5%
Bruise/contusion51.3%
Bone fracture(s)30.8%
Abrasion20.5%
Complaint, ill-defined20.5%
Laceration(s)20.5%
Ambulation or postural difficulties10.3%
Cognitive changes10.3%
Painpain, site not specified10.3%
Skin irritationirritated skin10.3%
Swellingswelling10.3%
Tissue breakdown10.3%

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

In context

MeasureM51p Blue Base W/Mk5 Nx Spj+ 9153642087Product code ITIAll MAUDE reports
Reports39530,58626,136,888
Share of that pool—1.3%0%
Classified as death, per 1,000 reports069
Classified as injury2.3%9.8%36.2%
Classified as malfunction97.7%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
Powered Wheelchair18,46400.1%
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%
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 M51p Blue Base W/Mk5 Nx Spj+ 9153642087 reports

How many FDA reports name M51p Blue Base W/Mk5 Nx Spj+ 9153642087?

395 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 (97.7%) and injury (2.3%). "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 (21.8%), mechanical problem (14.2%), break (12.2%), device displays incorrect message (6.3%) and leak/splash (5.6%). 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 M51p Blue Base W/Mk5 Nx Spj+ 9153642087 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.