Reported Reactions

Devices › Bed, ac-powered adjustable hospital

Device brand name · A/c powered hospital bed

Secure Acute Care Bed: medical device reports filed with FDA

295 reports name it, 2010–2012. Manufacturer given most often on reports: Stryker Medical. Product code FNL.

295
device reports naming the brand
0% of all MAUDE reports · about 18 a year
0
reports, 12 months to August 2026
0 in the 12 months before
98.6%
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 295 reports that name the brand "Secure Acute Care Bed" (a/c powered hospital bed), received between April 2010 and December 2012; the manufacturer given most often on reports is Stryker Medical. Spellings of one product vary from report to report.

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 (98.6%) and other (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 break (26.4%), component missing (18.3%) and device inoperable (11.2%). The patient problems coded most often are 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

No report naming Secure Acute Care Bed was received in the five years to August 2026; the latest was received in December 2012.

By year received

0911822010: 2720102011: 18220112012: 862012

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction98.6%291
Other1%3
Not given0.3%1

Who filed the report

Manufacturer report100%295
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
Breakthe device broke7826.4%9.4%
Component missing5418.3%2.2%
Device inoperablethe device could not be used3311.2%5.1%
Sticking289.5%9.7%
Device slipped196.4%16.6%
Device alarm system175.8%8.2%
Device operates differently than expectedthe device behaved unexpectedly124.1%5.5%
Failure to power up113.7%0.8%
Unintended system motionthe device moved when it should not have103.4%5.3%
Crackthe device cracked93.1%0.8%
Loss of powerthe device lost power93.1%0.9%
Device dislodged or dislocated82.7%0.2%
Material frayed82.7%0.4%
Torn material82.7%0.2%
Bent72.4%1.5%
Detachment of device component62%1.4%
Mechanical problema mechanical problem51.7%2.8%
False reading from device non-compliance41.4%1.9%
Unintended head motion41.4%4%
Display or visual feedback problem31%0.3%

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
No patient involvement5619%

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

In context

MeasureSecure Acute Care BedProduct code FNLAll MAUDE reports
Reports29594,20226,136,888
Share of that pool—0.3%0%
Classified as death, per 1,000 reports079
Classified as injury0%2%36.2%
Classified as malfunction98.6%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 Secure Acute Care Bed reports

How many FDA reports name Secure Acute Care Bed?

295 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 (98.6%) and other (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (26.4%), component missing (18.3%), device inoperable (11.2%), sticking (9.5%) and device slipped (6.4%). 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 Secure Acute Care 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.