Reported Reactions

Devices › Bed, ac-powered adjustable hospital

Device brand name · Bed ac-powered adjustable hospital

Citadel bed frame: medical device reports filed with FDA

215 reports name it, 2019–2026. Manufacturer given most often on reports: Arjohuntleigh Polska Sp Z O O. Product code FNL.

215
device reports naming the brand
0% of all MAUDE reports · about 32 a year
49
reports, 12 months to August 2026
51 in the 12 months before
80.5%
classified as malfunction
95.5% across the product code
1.9%
classified as death, as reported
4 reports · not verified by FDA

FDA's MAUDE database holds 215 reports that name the brand "Citadel bed frame" (bed ac-powered adjustable hospital), received between October 2019 and August 2026; the manufacturer given most often on reports is Arjohuntleigh Polska Sp Z O O. Spellings of one product vary from report to report.

49 reports arrived in the 12 months to August 2026, close to the 51 of 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 (80.5%), injury (17.7%) and death (1.9%); 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 unintended movement (27.4%), detachment of device or device component (21.4%) and activation problem (6.5%). The patient problems coded most often are fall, bone fracture(s) and bradycardia. 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

059Sep 2021: 4Oct 2021: 0Nov 2021: 2Dec 2021: 22022Jan 2022: 4Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 1Jul 2022: 3Aug 2022: 2Sep 2022: 0Oct 2022: 1Nov 2022: 4Dec 2022: 22023Jan 2023: 2Feb 2023: 1Mar 2023: 1Apr 2023: 3May 2023: 2Jun 2023: 4Jul 2023: 6Aug 2023: 2Sep 2023: 3Oct 2023: 4Nov 2023: 2Dec 2023: 42024Jan 2024: 1Feb 2024: 7Mar 2024: 2Apr 2024: 5May 2024: 5Jun 2024: 3Jul 2024: 5Aug 2024: 4Sep 2024: 4Oct 2024: 4Nov 2024: 4Dec 2024: 42025Jan 2025: 3Feb 2025: 5Mar 2025: 9Apr 2025: 4May 2025: 3Jun 2025: 2Jul 2025: 4Aug 2025: 5Sep 2025: 1Oct 2025: 6Nov 2025: 4Dec 2025: 32026Jan 2026: 4Feb 2026: 2Mar 2026: 4Apr 2026: 3May 2026: 5Jun 2026: 7Jul 2026: 8Aug 2026: 2

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

025492019: 520192020: 1320202021: 1420212022: 1720222023: 3420232024: 4820242025: 4920252026: 352026

Event type and report source

Event type, as classified on the report

Death1.9%4
Injury17.7%38
Malfunction80.5%173
Other0%0
Not given0%0

Who filed the report

Manufacturer report94.4%203
Voluntary report0.5%1
User facility report0%0
Distributor report5.1%11
Not given0%0

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
Unintended movement5927.4%2.9%
Detachment of device or device componentpart of the device came off4621.4%0.7%
Activation problem146.5%0.3%
Sparking136%0.3%
Insufficient device problem information94.2%0.6%
Breakthe device broke73.3%9.4%
Smoking41.9%0.2%
Electrical shorting31.4%0.2%
Mechanical problema mechanical problem31.4%2.8%
Failure to run on battery20.9%0%
Patient device interaction problem20.9%0%
Positioning failure20.9%0.4%
Component misassembled10.5%0%
Failure to capture10.5%0%
Fire10.5%0.2%
Misassembled during installation10.5%0%
No audible alarm10.5%1.9%
Overheating of device10.5%0%
Protective measures problem10.5%0%
Unclear information10.5%0.1%

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
Falla fall5927.4%
Bone fracture(s)41.9%
Bradycardiaslow heart rate41.9%
Hip fracturea broken hip41.9%
Laceration(s)41.9%
Convulsion/seizure31.4%
Hematomaa collection of blood under the skin or in tissue31.4%
Hemorrhage/blood loss/bleeding31.4%
No patient involvement31.4%
Bruise/contusion20.9%
Hypoxialow oxygen20.9%
Low oxygen saturation20.9%
Painpain, site not specified20.9%
Physical entrapment20.9%
Respiratory arrestbreathing stopped20.9%

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

In context

MeasureCitadel bed frameProduct code FNLAll MAUDE reports
Reports21594,20226,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports1979
Classified as injury17.7%2%36.2%
Classified as malfunction80.5%95.5%62.3%
Filed by the manufacturer94.4%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 Citadel bed frame reports

How many FDA reports name Citadel bed frame?

215 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 49 in the latest 12 months.

What kinds of events are reported?

malfunction (80.5%), injury (17.7%) and death (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

unintended movement (27.4%), detachment of device or device component (21.4%), activation problem (6.5%), sparking (6%) and insufficient device problem information (4.2%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (94.4%), distributor reports (5.1%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Citadel bed frame 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.