Reported Reactions

Devices › Bed, ac-powered adjustable hospital

Device brand name · A/c powered adjustable hospital bed

Advanta 2 Bed: medical device reports filed with FDA

357 reports name it, 2012–2026. Manufacturer given most often on reports: Hillrom De Mexico S De Rl De Cv. Product code FNL.

357
device reports naming the brand
0% of all MAUDE reports · about 25 a year
39
reports, 12 months to August 2026
25 in the 12 months before
94.7%
classified as malfunction
95.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 357 reports that name the brand "Advanta 2 Bed" (a/c powered adjustable hospital bed), received between January 2012 and August 2026; the manufacturer given most often on reports is Hillrom De Mexico S De Rl De Cv. Spellings of one product vary from report to report.

39 reports arrived in the 12 months to August 2026, up 56% from 25 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 (94.7%), injury (1.4%) and other (1.4%); 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 device alarm system (23.2%), insufficient device problem information (17.9%) and unintended movement (12.3%). The patient problems coded most often are fall, injury and no patient involvement. 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: 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: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 2Feb 2025: 2Mar 2025: 7Apr 2025: 7May 2025: 4Jun 2025: 0Jul 2025: 2Aug 2025: 1Sep 2025: 1Oct 2025: 3Nov 2025: 3Dec 2025: 12026Jan 2026: 6Feb 2026: 3Mar 2026: 3Apr 2026: 7May 2026: 1Jun 2026: 4Jul 2026: 4Aug 2026: 3

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

0811622012: 2320122013: 16220132014: 6520142015: 3520152016: 820162025: 3320252026: 312026

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.4%5
Malfunction94.7%338
Other1.4%5
Not given2.5%9

Who filed the report

Manufacturer report77.3%276
Voluntary report0%0
User facility report0%0
Distributor report22.7%81
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
Device alarm system8323.2%8.2%
Insufficient device problem information6417.9%0.6%
Unintended movement4412.3%2.9%
Electrical /electronic property probleman electrical or electronic problem3610.1%1.4%
Mechanical problema mechanical problem287.8%2.8%
Device inoperablethe device could not be used133.6%5.1%
Device slipped102.8%16.6%
Material split, cut or torn102.8%4.3%
Activation problem72%0.3%
Communication or transmission problemthe device could not communicate or transmit72%0.2%
Device operates differently than expectedthe device behaved unexpectedly72%5.5%
Component falling51.4%0.3%
Collapse41.1%0.4%
Detachment of device component41.1%1.4%
No audible alarm30.8%1.9%
Self-activation or keying30.8%0.5%
Breakthe device broke20.6%9.4%
Defective alarm20.6%0.6%
Detachment of device or device componentpart of the device came off20.6%0.7%
Foreign material20.6%0%

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 fall72%
Injurya physical injury20.6%
No patient involvement10.3%

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

In context

MeasureAdvanta 2 BedProduct code FNLAll MAUDE reports
Reports35794,20226,136,888
Share of that pool—0.4%0%
Classified as death, per 1,000 reports079
Classified as injury1.4%2%36.2%
Classified as malfunction94.7%95.5%62.3%
Filed by the manufacturer77.3%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 Advanta 2 Bed reports

How many FDA reports name Advanta 2 Bed?

357 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 39 in the latest 12 months.

What kinds of events are reported?

malfunction (94.7%), injury (1.4%) and other (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device alarm system (23.2%), insufficient device problem information (17.9%), unintended movement (12.3%), electrical /electronic property problem (10.1%) and mechanical problem (7.8%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (77.3%) and distributor reports (22.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Advanta 2 Bed 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.