Reported Reactions

Devices › Bed, ac-powered adjustable hospital

Device brand name · Bed ac-powered adjustable hospital

In Touch Zu: medical device reports filed with FDA

2,342 reports name it, 2009–2014. Manufacturer given most often on reports: Stryker Medical-Kalamazoo. Product code FNL.

2,342
device reports naming the brand
0% of all MAUDE reports · about 135 a year
0
reports, 12 months to August 2026
0 in the 12 months before
96.1%
classified as malfunction
95.5% across the product code
0.1%
classified as death, as reported
2 reports · not verified by FDA

2,342 medical device reports received by FDA name the brand "In Touch Zu" (bed ac-powered adjustable hospital); the manufacturer given most often on reports is Stryker Medical-Kalamazoo; received from February 2009 to June 2014. 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 (96.1%), other (1.1%) and injury (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 (35.7%), device slipped (20.8%) and device inoperable (10.7%). The patient problems coded most often are no patient involvement, pressure sore/ulcer and injury. 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 In Touch Zu was received in the five years to August 2026; the latest was received in June 2014.

By year received

04549082009: 1320092010: 6820102011: 40920112012: 70820122013: 90820132014: 2362014

Event type and report source

Event type, as classified on the report

Death0.1%2
Injury1%23
Malfunction96.1%2,250
Other1.1%25
Not given1.8%42

Who filed the report

Manufacturer report100%2,342
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 broke83535.7%9.4%
Device slipped48820.8%16.6%
Device inoperablethe device could not be used25110.7%5.1%
Device operates differently than expectedthe device behaved unexpectedly2199.4%5.5%
Sticking1637%9.7%
Device stops intermittentlythe device stopped now and then1094.7%0.5%
Failure to power up934%0.8%
Device alarm system923.9%8.2%
Bent763.2%1.5%
Detachment of device component713%1.4%
False reading from device non-compliance652.8%1.9%
Loss of powerthe device lost power552.3%0.9%
Component missing512.2%2.2%
Crackthe device cracked482%0.8%
Scratched material391.7%0.8%
Material frayed381.6%0.4%
Calibration problem341.5%0.5%
Cut in material321.4%0.6%
Power problem311.3%0.3%
Device displays incorrect message291.2%0.6%

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 involvement1436.1%
Pressure sore/ulcer110.5%
Injurya physical injury70.3%
Electric shockan electric shock50.2%
Falla fall50.2%
Physical entrapment20.1%
Abrasion10%
Ambulation or postural difficulties10%
Anxietyanxiety10%
Bone fracture(s)10%
Deaththe patient died; cause not stated by this term10%
Dyspneashortness of breath10%
Shockshock, a collapse of the circulation10%
Skin tears10%
Sprain10%

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

In context

MeasureIn Touch ZuProduct code FNLAll MAUDE reports
Reports2,34294,20226,136,888
Share of that pool—2.5%0%
Classified as death, per 1,000 reports179
Classified as injury1%2%36.2%
Classified as malfunction96.1%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%
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%
Progressa Frame1,20770.1%

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 In Touch Zu reports

How many FDA reports name In Touch Zu?

2,342 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 (96.1%), other (1.1%) and injury (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (35.7%), device slipped (20.8%), device inoperable (10.7%), device operates differently than expected (9.4%) and sticking (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 In Touch Zu 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.