Reported Reactions

Devices › Bed, ac-powered adjustable hospital

Device brand name · Bed ac-powered adjustable hospital

Spirit Select: medical device reports filed with FDA

1,081 reports name it, 2015–2025. Manufacturer given most often on reports: Stryker Medical London Chg Hospital Beds. Product code FNL.

1,081
device reports naming the brand
0% of all MAUDE reports · about 94 a year
1
reports, 12 months to August 2026
14 in the 12 months before
96.2%
classified as malfunction
95.5% across the product code
0.2%
classified as death, as reported
2 reports · not verified by FDA

FDA's MAUDE database holds 1,081 reports that name the brand "Spirit Select" (bed ac-powered adjustable hospital), received between January 2015 and October 2025; the manufacturer given most often on reports is Stryker Medical London Chg Hospital Beds. Spellings of one product vary from report to report.

1 reports arrived in the 12 months to August 2026, down 93% from 14 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 (96.2%), injury (3.5%) and death (0.2%); across all bed, ac-powered adjustable hospital reports (product code FNL) death is recorded in 0.7% and malfunction in 95.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (25.1%), device alarm system (7.7%) and incorrect measurement (7.4%). The patient problems coded most often are no patient involvement, fall and injury. 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

047Sep 2021: 0Oct 2021: 7Nov 2021: 1Dec 2021: 02022Jan 2022: 6Feb 2022: 0Mar 2022: 0Apr 2022: 4May 2022: 0Jun 2022: 0Jul 2022: 3Aug 2022: 0Sep 2022: 0Oct 2022: 5Nov 2022: 0Dec 2022: 02023Jan 2023: 3Feb 2023: 0Mar 2023: 0Apr 2023: 3May 2023: 0Jun 2023: 0Jul 2023: 4Aug 2023: 0Sep 2023: 0Oct 2023: 6Nov 2023: 1Dec 2023: 02024Jan 2024: 4Feb 2024: 0Mar 2024: 0Apr 2024: 2May 2024: 0Jun 2024: 0Jul 2024: 3Aug 2024: 0Sep 2024: 0Oct 2024: 4Nov 2024: 0Dec 2024: 02025Jan 2025: 3Feb 2025: 0Mar 2025: 0Apr 2025: 5May 2025: 1Jun 2025: 0Jul 2025: 1Aug 2025: 0Sep 2025: 0Oct 2025: 1Nov 2025: 0Dec 2025: 02026Jan 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

01983962015: 39620152016: 2192017: 15720172018: 1502019: 3220192020: 282021: 4020212022: 182023: 1720232024: 132025: 112025

Event type and report source

Event type, as classified on the report

Death0.2%2
Injury3.5%38
Malfunction96.2%1,040
Other0%0
Not given0.1%1

Who filed the report

Manufacturer report99.1%1,071
Voluntary report0%0
User facility report0%0
Distributor report0.3%3
Not given0.6%7

Grey bar: all 94,202 reports carrying product code FNL. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Breakthe device broke27125.1%9.4%
Device alarm system837.7%8.2%
Incorrect measurementthe device measured wrongly807.4%1.3%
Electrical /electronic property probleman electrical or electronic problem797.3%1.4%
Device operates differently than expectedthe device behaved unexpectedly696.4%5.5%
Bent666.1%1.5%
Mechanical problema mechanical problem464.3%2.8%
False reading from device non-compliance403.7%1.9%
Cut in material393.6%0.6%
Failure to zero393.6%0.2%
Incorrect or inadequate test results383.5%0.1%
Unintended system motionthe device moved when it should not have323%5.3%
Calibration problem312.9%0.5%
No audible alarm302.8%1.9%
Incorrect, inadequate or imprecise result or readings272.5%0.1%
Detachment of device component252.3%1.4%
Device slipped242.2%16.6%
Scratched material181.7%0.8%
Unintended movement181.7%2.9%
Positioning failure171.6%0.4%

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 involvement716.6%
Falla fall615.6%
Injurya physical injury90.8%
Bone fracture(s)70.6%
Abrasion60.6%
Laceration(s)60.6%
Deaththe patient died; cause not stated by this term30.3%
Painpain, site not specified30.3%
Bruise/contusion20.2%
Electric shockan electric shock20.2%
Overdosea dose above the recommended amount20.2%
Skin tears20.2%
Head injurya head injury10.1%
Hip fracturea broken hip10.1%
Shockshock, a collapse of the circulation10.1%

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

In context

MeasureSpirit SelectProduct code FNLAll MAUDE reports
Reports1,08194,20226,136,888
Share of that pool—1.1%0%
Classified as death, per 1,000 reports279
Classified as injury3.5%2%36.2%
Classified as malfunction96.2%95.5%62.3%
Filed by the manufacturer99.1%97.6%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 FNL

BrandReportsLatest 12 monthsClassified as death
Totalcare6,66100%
Versacare Bed4,72500.2%
TotalCare Bed4,1382740%
Versacare3,30300.1%
Secure 3 Med/Surg Bed2,48400.1%
Versacare Frame2,37200.2%
In Touch Zu2,34200.1%
Centra Bed2,21400.1%
Advanta Bed2,18750.3%
CareAssist Bed2,106490%
Ac-Powered Adjustable Hospital Bed Including Rails2,16701.3%
Century Bed1,38600.4%
Secure 3 Med/Surg Bedobs 01/131,34880.1%
4 Motor Advance Bed1,33900.4%
Centrella Bed1,3347980.2%

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 Spirit Select reports

How many FDA reports name Spirit Select?

1,081 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.

What kinds of events are reported?

malfunction (96.2%), injury (3.5%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (25.1%), device alarm system (7.7%), incorrect measurement (7.4%), electrical /electronic property problem (7.3%) and device operates differently than expected (6.4%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.1%) and distributor reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Spirit Select 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.