Reported Reactions

Devices › Bed, ac-powered adjustable hospital

Device brand name · Bed ac-powered adjustable hospital

Progressa Frame: medical device reports filed with FDA

1,207 reports name it, 2015–2025. Manufacturer given most often on reports: Hill-Rom Batesville. Product code FNL.

1,207
device reports naming the brand
0% of all MAUDE reports · about 111 a year
7
reports, 12 months to August 2026
64 in the 12 months before
87.7%
classified as malfunction
95.5% across the product code
0.1%
classified as death, as reported
1 reports · not verified by FDA

FDA's MAUDE database holds 1,207 reports that name the brand "Progressa Frame" (bed ac-powered adjustable hospital), received between August 2015 and November 2025; the manufacturer given most often on reports is Hill-Rom Batesville. Spellings of one product vary from report to report.

7 reports arrived in the 12 months to August 2026, down 89% from 64 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 (87.7%), injury (12.3%) and death (0.1%); 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 (44%), unintended movement (11.7%) and no audible alarm (7.6%). The patient problems coded most often are pressure sore/ulcer, no patient involvement and erythema. 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

02549Sep 2021: 2Oct 2021: 3Nov 2021: 16Dec 2021: 262022Jan 2022: 9Feb 2022: 21Mar 2022: 15Apr 2022: 30May 2022: 11Jun 2022: 17Jul 2022: 3Aug 2022: 9Sep 2022: 11Oct 2022: 9Nov 2022: 9Dec 2022: 62023Jan 2023: 10Feb 2023: 7Mar 2023: 29Apr 2023: 40May 2023: 45Jun 2023: 42Jul 2023: 40Aug 2023: 36Sep 2023: 28Oct 2023: 15Nov 2023: 34Dec 2023: 292024Jan 2024: 32Feb 2024: 25Mar 2024: 29Apr 2024: 27May 2024: 37Jun 2024: 39Jul 2024: 45Aug 2024: 49Sep 2024: 30Oct 2024: 10Nov 2024: 3Dec 2024: 72025Jan 2025: 6Feb 2025: 0Mar 2025: 0Apr 2025: 1May 2025: 4Jun 2025: 2Jul 2025: 1Aug 2025: 0Sep 2025: 2Oct 2025: 1Nov 2025: 4Dec 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

01783552015: 820152016: 242017: 3520172018: 412019: 4520192020: 722021: 12320212022: 1502023: 35520232024: 3332025: 212025

Event type and report source

Event type, as classified on the report

Death0.1%1
Injury12.3%148
Malfunction87.7%1,058
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,207
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 torn53144%4.3%
Unintended movement14111.7%2.9%
No audible alarm927.6%1.9%
Unclear information685.6%0.1%
Device alarm system665.5%8.2%
Defective alarm524.3%0.6%
Pressure problem393.2%0%
Activation problem312.6%0.3%
Material frayed272.2%0.4%
Device slipped191.6%16.6%
Insufficient device problem information191.6%0.6%
Self-activation or keying161.3%0.5%
Unintended system motionthe device moved when it should not have141.2%5.3%
Sparking90.7%0.3%
Breakthe device broke70.6%9.4%
Mechanical problema mechanical problem60.5%2.8%
Communication or transmission problemthe device could not communicate or transmit50.4%0.2%
Arcing40.3%0.3%
Device operates differently than expectedthe device behaved unexpectedly40.3%5.5%
Electrical shorting40.3%0.2%

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
Pressure sore/ulcer13411.1%
No patient involvement12810.6%
Erythemaskin redness70.6%
Blistera blister40.3%
Falla fall20.2%
Contact dermatitis10.1%
Electric shockan electric shock10.1%
Hematomaa collection of blood under the skin or in tissue10.1%
Hip fracturea broken hip10.1%
Injurya physical injury10.1%
Osteomyelitis10.1%
Painpain, site not specified10.1%
Ventilator dependent10.1%

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

In context

MeasureProgressa FrameProduct code FNLAll MAUDE reports
Reports1,20794,20226,136,888
Share of that pool—1.3%0%
Classified as death, per 1,000 reports179
Classified as injury12.3%2%36.2%
Classified as malfunction87.7%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 Progressa Frame reports

How many FDA reports name Progressa Frame?

1,207 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 (87.7%), injury (12.3%) and death (0.1%). "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 (44%), unintended movement (11.7%), no audible alarm (7.6%), unclear information (5.6%) and device alarm system (5.5%). 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 Progressa 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.