Reported Reactions

Devices › Bed, ac-powered adjustable hospital

Device brand name · Bed ac-powered adjustable hospital

VersaCare Med Surg Bed: medical device reports filed with FDA

1,152 reports name it, 2024–2026. Manufacturer given most often on reports: Baxter Healthcare. Product code FNL.

1,152
device reports naming the brand
0% of all MAUDE reports · about 631 a year
661
reports, 12 months to August 2026
491 in the 12 months before
99.3%
classified as malfunction
95.5% across the product code
0.3%
classified as death, as reported
3 reports · not verified by FDA

1,152 medical device reports received by FDA name the brand "VersaCare Med Surg Bed" (bed ac-powered adjustable hospital); the manufacturer given most often on reports is Baxter Healthcare; received from September 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

661 reports arrived in the 12 months to August 2026, up 35% from 491 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 (99.3%), injury (0.4%) and death (0.3%); 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 material split, cut or torn (60.2%), unintended movement (32.2%) and no audible alarm (3.7%). The patient problems coded most often are fall, bone fracture(s) and hip fracture. 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

04182Sep 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: 1Oct 2024: 16Nov 2024: 65Dec 2024: 482025Jan 2025: 69Feb 2025: 61Mar 2025: 45Apr 2025: 46May 2025: 38Jun 2025: 39Jul 2025: 33Aug 2025: 30Sep 2025: 50Oct 2025: 35Nov 2025: 67Dec 2025: 522026Jan 2026: 50Feb 2026: 48Mar 2026: 82Apr 2026: 63May 2026: 59Jun 2026: 48Jul 2026: 53Aug 2026: 54

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

02835652024: 13020242025: 56520252026: 4572026

Event type and report source

Event type, as classified on the report

Death0.3%3
Injury0.4%5
Malfunction99.3%1,144
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,152
Voluntary report0%0
User facility report0%0
Distributor report0%0
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
Material split, cut or torn69360.2%4.3%
Unintended movement37132.2%2.9%
No audible alarm433.7%1.9%
Activation problem111%0.3%
Collapse80.7%0.4%
Defective alarm50.4%0.6%
Material frayed50.4%0.4%
Sparking50.4%0.3%
Arcing20.2%0.3%
Improper or incorrect procedure or method20.2%0.2%
Intermittent continuity20.2%0%
Device dislodged or dislocated10.1%0.2%
Flare or flash10.1%0%
Insufficient device problem information10.1%0.6%
Unintended system motionthe device moved when it should not have10.1%5.3%

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 fall50.4%
Bone fracture(s)20.2%
Hip fracturea broken hip20.2%
Appropriate clinical signs, symptoms and conditions term/code not available10.1%
Intracranial hemorrhage10.1%
Painpain, site not specified10.1%

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

In context

MeasureVersaCare Med Surg BedProduct code FNLAll MAUDE reports
Reports1,15294,20226,136,888
Share of that pool—1.2%0%
Classified as death, per 1,000 reports379
Classified as injury0.4%2%36.2%
Classified as malfunction99.3%95.5%62.3%
Filed by the manufacturer100%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 VersaCare Med Surg Bed reports

How many FDA reports name VersaCare Med Surg Bed?

1,152 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 661 in the latest 12 months.

What kinds of events are reported?

malfunction (99.3%), injury (0.4%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material split, cut or torn (60.2%), unintended movement (32.2%), no audible alarm (3.7%), activation problem (1%) and collapse (0.7%). 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 VersaCare Med Surg 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.