Reported Reactions

Devices › Bed, ac-powered adjustable hospital

Device brand name · A/c powered adjustable hospital bed

Totalcare-Treat Surface & Scale Total Care Frame: medical device reports filed with FDA

180 reports name it, 2009–2010. Manufacturer given most often on reports: Hill-Rom Ritter. Product code FNL.

180
device reports naming the brand
0% of all MAUDE reports · about 10 a year
0
reports, 12 months to August 2026
0 in the 12 months before
100%
classified as malfunction
95.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

180 medical device reports received by FDA name the brand "Totalcare-Treat Surface & Scale Total Care Frame" (a/c powered adjustable hospital bed); the manufacturer given most often on reports is Hill-Rom Ritter; received from January 2009 to June 2010. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (100%); 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 sticking (28.9%), unintended head motion (17.2%) and device slipped (16.7%). The patient problems coded most often are electric shock and physical entrapment. 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

No report naming Totalcare-Treat Surface & Scale Total Care Frame was received in the five years to August 2026; the latest was received in June 2010.

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction100%180
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%180
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
Sticking5228.9%9.7%
Unintended head motion3117.2%4%
Device slipped3016.7%16.6%
Unintended system motionthe device moved when it should not have1810%5.3%
Device inoperablethe device could not be used158.3%5.1%
Moisture damage73.9%0.7%
Device operates differently than expectedthe device behaved unexpectedly52.8%5.5%
Breakthe device broke31.7%9.4%
Cut in material31.7%0.6%
Device alarm system31.7%8.2%
Detachment of device component21.1%1.4%
Electrical shorting21.1%0.2%
Fluid/blood leak21.1%0.1%
Mechanical problema mechanical problem21.1%2.8%
Naturally worn21.1%0.6%
Repair21.1%2.3%
Bent10.6%1.5%
Decrease in pressure10.6%0%
Device damaged prior to usethe device was damaged before use10.6%0.1%
Disconnection10.6%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
Electric shockan electric shock10.6%
Physical entrapment10.6%

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

In context

MeasureTotalcare-Treat Surface & Scale Total Care FrameProduct code FNLAll MAUDE reports
Reports18094,20226,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports079
Classified as injury0%2%36.2%
Classified as malfunction100%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 Totalcare-Treat Surface & Scale Total Care Frame reports

How many FDA reports name Totalcare-Treat Surface & Scale Total Care Frame?

180 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

sticking (28.9%), unintended head motion (17.2%), device slipped (16.7%), unintended system motion (10%) and device inoperable (8.3%). 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 Totalcare-Treat Surface & Scale Total Care 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.