Reported Reactions

Devices › Stretcher, wheeled

Device brand name · Hospital wheeled stretcher

Stretcher: medical device reports filed with FDA

248 reports name it, 2009–2025. Manufacturer given most often on reports: Stryker Medical. Product code FPO.

248
device reports naming the brand
0% of all MAUDE reports · about 14 a year
7
reports, 12 months to August 2026
3 in the 12 months before
95.6%
classified as malfunction
93.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 248 reports that name the brand "Stretcher" (hospital wheeled stretcher), received between March 2009 and December 2025; the manufacturer given most often on reports is Stryker Medical. Spellings of one product vary from report to report.

7 reports arrived in the 12 months to August 2026, up 133% from 3 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 (95.6%) and other (2.8%); across all stretcher, wheeled reports (product code FPO) death is recorded in 0.3% and malfunction in 93.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device slipped (25.4%), sticking (16.1%) and mechanical problem (13.7%). The patient problems coded most often are no patient involvement, appropriate clinical signs, symptoms and conditions term/code not available and hearing impairment. 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

01427Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 2May 2023: 0Jun 2023: 0Jul 2023: 27Aug 2023: 19Sep 2023: 0Oct 2023: 0Nov 2023: 14Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 2Apr 2024: 1May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 3Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 2Feb 2025: 1Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 1Oct 2025: 0Nov 2025: 0Dec 2025: 62026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

038752009: 1420092010: 4520102011: 7520112012: 3620122023: 6220232024: 620242025: 102025

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction95.6%237
Other2.8%7
Not given1.6%4

Who filed the report

Manufacturer report70.2%174
Voluntary report29%72
User facility report0%0
Distributor report0%0
Not given0.8%2

Grey bar: all 35,248 reports carrying product code FPO. 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 slipped6325.4%33.9%
Sticking4016.1%8.9%
Mechanical problema mechanical problem3413.7%5.5%
Device operates differently than expectedthe device behaved unexpectedly208.1%5.2%
Device inoperablethe device could not be used176.9%1.9%
Breakthe device broke135.2%11.8%
Fluid/blood leak135.2%2.3%
Fail-safe did not operate62.4%0%
Protective measures problem62.4%0.4%
Unintended system motionthe device moved when it should not have62.4%3.5%
Failure to pump52%0.8%
Mechanics altered52%0.1%
Component missing41.6%3.3%
Therapeutic or diagnostic output failure41.6%0%
Degraded31.2%0%
Fail-safe problem31.2%0%
Unintended head motion31.2%1.8%
Defective component20.8%0.1%
Disassembly20.8%0%
Leak/splashthe device leaked20.8%1.1%

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
No patient involvement187.3%
Appropriate clinical signs, symptoms and conditions term/code not available10.4%
Hearing impairment10.4%
Injurya physical injury10.4%
Muscle weakness/atrophy10.4%

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

In context

MeasureStretcherProduct code FPOAll MAUDE reports
Reports24835,24826,136,888
Share of that pool—0.7%0%
Classified as death, per 1,000 reports039
Classified as injury0%3.4%36.2%
Classified as malfunction95.6%93.7%62.3%
Filed by the manufacturer70.2%98.1%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 FPO

BrandReportsLatest 12 monthsClassified as death
Transtar Stretcher5,75150%
Sm204 M-Series W/Big Wheel2,79670%
Power Pro Ambulance Cot3,61500.4%
Sm104 M-Series W/5th Wheel98500%
Procedural stretcher9282110%
Mx-Pro R-3 Ambulance Cot99441.5%
Sm104 Mseries W5th Whl87400%
Power Pro Ambulance Cot - Obs657111.4%
Advantage Series 2664000%
Eye Surgery Stretcher590150%
Sm104 Mseries W5th Whlobs3/0751950.4%
Gynnie Ob-Gyn Stretcher563110%
Power Load46381.5%
Prime Big Wheel Stretcher 30444210%
Advantage Series 2944600%

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 Stretcher reports

How many FDA reports name Stretcher?

248 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 7 in the latest 12 months.

What kinds of events are reported?

malfunction (95.6%) and other (2.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device slipped (25.4%), sticking (16.1%), mechanical problem (13.7%), device operates differently than expected (8.1%) and device inoperable (6.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (70.2%) and voluntary reports (29%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Stretcher 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.