Devices › Bed, ac-powered adjustable hospital
Device brand name · Bed ac-powered adjustable hospital
Enterprise 9000x: medical device reports filed with FDA
161 reports name it, 2017–2026. Manufacturer given most often on reports: Arjohuntleigh Polska Sp Z O O. Product code FNL.
- 161
- device reports naming the brand
- 0% of all MAUDE reports · about 17 a year
- 14
- reports, 12 months to August 2026
- 28 in the 12 months before
- 81.4%
- classified as malfunction
- 95.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
161 medical device reports received by FDA name the brand "Enterprise 9000x" (bed ac-powered adjustable hospital); the manufacturer given most often on reports is Arjohuntleigh Polska Sp Z O O; received from February 2017 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
14 reports arrived in the 12 months to August 2026, down 50% from 28 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 (81.4%) and injury (18.6%); 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 unintended movement (45.3%), detachment of device or device component (16.8%) and circuit failure (5.6%). The patient problems coded most often are fall, no patient involvement 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
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) | Reports | Share | Share across product code |
|---|---|---|---|
| Unintended movement | 73 | 45.3% | 2.9% |
| Detachment of device or device componentpart of the device came off | 27 | 16.8% | 0.7% |
| Circuit failure | 9 | 5.6% | 0.1% |
| Mechanical problema mechanical problem | 9 | 5.6% | 2.8% |
| Sparking | 6 | 3.7% | 0.3% |
| Fracturea broken bone | 3 | 1.9% | 0.1% |
| Device fell | 2 | 1.2% | 0.3% |
| Device inoperablethe device could not be used | 2 | 1.2% | 5.1% |
| Material twisted/bent | 2 | 1.2% | 0.1% |
| Activation problem | 1 | 0.6% | 0.3% |
| Activation, positioning or separation problem | 1 | 0.6% | 0% |
| Collapse | 1 | 0.6% | 0.4% |
| Component missing | 1 | 0.6% | 2.2% |
| Delayed alarm | 1 | 0.6% | 0% |
| Electrical /electronic property probleman electrical or electronic problem | 1 | 0.6% | 1.4% |
| Human factors issue | 1 | 0.6% | 0% |
| Insufficient device problem information | 1 | 0.6% | 0.6% |
| Non reproducible results | 1 | 0.6% | 0% |
| Positioning problem | 1 | 0.6% | 0.3% |
| Smoking | 1 | 0.6% | 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) | Reports | Share |
|---|---|---|
| Falla fall | 10 | 6.2% |
| No patient involvement | 7 | 4.3% |
| Hip fracturea broken hip | 4 | 2.5% |
| Head injurya head injury | 2 | 1.2% |
| Injurya physical injury | 2 | 1.2% |
| Unintended extubation | 2 | 1.2% |
| Bruise/contusion | 1 | 0.6% |
| Cardiac arrestthe heart stopped | 1 | 0.6% |
| Deaththe patient died; cause not stated by this term | 1 | 0.6% |
| Discomfortdiscomfort | 1 | 0.6% |
| Electric shockan electric shock | 1 | 0.6% |
| Localized skin lesion | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Enterprise 9000x | Product code FNL | All MAUDE reports |
|---|---|---|---|
| Reports | 161 | 94,202 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 7 | 9 |
| Classified as injury | 18.6% | 2% | 36.2% |
| Classified as malfunction | 81.4% | 95.5% | 62.3% |
| Filed by the manufacturer | 97.5% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Totalcare | 6,661 | 0 | 0% |
| Versacare Bed | 4,725 | 0 | 0.2% |
| TotalCare Bed | 4,138 | 274 | 0% |
| Versacare | 3,303 | 0 | 0.1% |
| Secure 3 Med/Surg Bed | 2,484 | 0 | 0.1% |
| Versacare Frame | 2,372 | 0 | 0.2% |
| In Touch Zu | 2,342 | 0 | 0.1% |
| Centra Bed | 2,214 | 0 | 0.1% |
| Advanta Bed | 2,187 | 5 | 0.3% |
| CareAssist Bed | 2,106 | 49 | 0% |
| Ac-Powered Adjustable Hospital Bed Including Rails | 2,167 | 0 | 1.3% |
| Century Bed | 1,386 | 0 | 0.4% |
| Secure 3 Med/Surg Bedobs 01/13 | 1,348 | 8 | 0.1% |
| 4 Motor Advance Bed | 1,339 | 0 | 0.4% |
| Centrella Bed | 1,334 | 798 | 0.2% |
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 Enterprise 9000x reports
How many FDA reports name Enterprise 9000x?
161 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 14 in the latest 12 months.
What kinds of events are reported?
malfunction (81.4%) and injury (18.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unintended movement (45.3%), detachment of device or device component (16.8%), circuit failure (5.6%), mechanical problem (5.6%) and sparking (3.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.5%) and distributor reports (2.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Enterprise 9000x 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.