EnterpriseRecalls & reported problems across all models
Arjohuntleigh AB · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 4 models of Enterprise by Arjohuntleigh AB in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2019 and Mar 3, 2026 — classified as 9 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (19 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Enterprise problems
Device problems
- Unintended Movement19
- Detachment of Device or Device Component12
- Use of Device Problem5
- Device Fell2
- Fracture2
- Activation Problem1
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Fall6
- No Consequences Or Impact To Patient6
- Head Injury2
- Hip Fracture2
- No Patient Involvement2
Enterprise models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Enterprise 9611AF101BCUSBBED, AC-POWERED ADJUSTABLE HOSPITAL32 reports
- Enterprise 9814DF101BCUSBBED, AC-POWERED ADJUSTABLE HOSPITAL8 reports
- Enterprise 9614DF101BCUSBBED, AC-POWERED ADJUSTABLE HOSPITAL1 report
- Enterprise 9714DF101BCUSBBED, AC-POWERED ADJUSTABLE HOSPITAL1 report
Recent Enterprise adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Detachment of Device or Device Component
ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE ENTERPRISE 9000X BED. THE CUSTOMER REPORTED THAT THE RIGHT HEAD SIDE RAIL WAS DAMAGED. THERE WAS NO PATIENT INVOLVED. NO INJURY WAS SUSTAINED. BASED ON THE INSPECTION FINDINGS AND THE PHOTOGRAPHIC EVIDENCE PROVIDED, THE CUSTOMER-REPORTED ISSUE WAS CONFIRMED. THE UPPER ARM OF THE SIDE RAIL WAS FOUND DETACHED, AND THE LOWER ARM WAS DISCONNECTED, RESULTING IN A PARTIAL DETACHMENT OF THE SIDE RAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494665 ↗MalfunctionFeb 20, 2026Detachment of Device or Device Component
DURING THE PICK UP OF THE BED, IT WAS OBSERVED THAT THE LEFT HEAD SIDE RAIL WAS DAMAGED. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURY WAS SUSTAINED. ADDITIONAL INFORMATION PROVIDED BY THE ARJO TECHNICIAN CONFIRMED THAT THE SIDE RAIL WAS DETACHED BECAUSE THE HOLDING-PANEL SCREWS HAD BEEN PULLED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24398600 ↗MalfunctionFeb 3, 2026Use of Device Problem
ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE ENTERPRISE 9000X BED. THE CUSTOMER REPORTED THAT THE BED ALARM WAS NOT WORKING, AND THE PATIENT FELL FROM THE BED. NO INJURY WAS SUSTAINED.
Patient problems: Fall
MAUDE report 24243925 ↗MalfunctionJan 16, 2026Fracture
THE CUSTOMER REPORTED THAT THE BACKREST FUNCTION ON THE ENTERPRISE 9000X BED WAS INOPERATIVE. NO INJURY WAS SUSTAINED. DURING THE EVALUATION, AN ARJO TECHNICIAN FOUND THAT THE BACKREST ACTUATOR AND DAMPENER HAD FAILED, AND THE BACKREST INNER HINGE WAS BROKEN. THE IDENTIFIED DAMAGES INDICATE THAT THE BACKREST LIKELY COLLAPSED WHILE THE BED WAS BEING USED BY A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24091199 ↗MalfunctionNov 5, 2025Unintended Movement; Unintended Movement
ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE ENTERPRISE 9000X BED. THE CUSTOMER REPORTED THAT THE BED WAS MOVING ON ITS OWN, STATING THAT THE ENTIRE BED WAS GOING UP AND DOWN WITHOUT ANY COMMAND. THE PATIENT WAS IN BED, AND NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23475296 ↗MalfunctionAug 26, 2025Device Fell; Device Fell
ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE ENTERPRISE 9000X BED, WHERE A PATIENT REPORTEDLY FELL FROM THE BED. ACCORDING TO THE CUSTOMER, THE SIDE RAIL DID NOT PREVENT THE PATIENT FROM EXITING THE BED. NO INJURY WAS SUSTAINED. DURING THE DEVICE INSPECTION, THE ARJO TECHNICIAN FOUND THAT THE SIDE RAIL LATCHING MECHANISM WAS NOT FULLY ENGAGING DUE TO INTERNAL DEBRIS OR AGED GREASE. LUBRICATION WAS APPLIED, AND NO SIDE RAIL PARTS REQUIRED REPLACEMENT. AFTER LUBRICATION, THE SIDE RAIL LOCKING MECHANISM OPERATED AS INTENDED.
Patient problems: Fall
MAUDE report 22892407 ↗MalfunctionAug 20, 2025Unintended Movement; Unintended Movement
DURING THE ON-SITE VISIT, THE ARJO TECHNICIAN NOTICED A NOTE LEFT ON THE ENTERPRISE 9000X BED SAYING THAT THE BED WAS GOING UP AND DOWN ON ITS OWN. THE BED WAS LEFT IN THE STORAGE ROOM. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22848284 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE SIDE RAIL WAS BROKEN AND DID NOT LOCK. THERE WAS A PATIENT ON THE BED WHEN THE EVENT OCCURRED. NO INJURY WAS SUSTAINED. DURING THE DEVICE INSPECTION, IT WAS FOUND THAT THE RIGHT BODY SIDE RAIL WAS SEPARATING FROM THE INSIDE COVER. IT WAS CONFIRMED THAT TWO SCREWS HAD BEEN PULLED OUT AND STUCK BETWEEN THE COVER PIECE AND THE BODY OF THE SIDE RAIL. THE SIDE RAIL WAS REPLACED. THE BED WAS TESTED AND WAS FULLY OPERATIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22392013 ↗MalfunctionMay 6, 2025Fracture; Fracture
CUSTOMER REPORTED THAT BACKREST OF THE ENTERPRISE 9000X BED WOULD NOT GO UP OR DOWN. AT THE TIME, BED WAS USED BY A PATIENT. NO INJURY WAS REPORTED. ARJO TECHNICIAN VISITED THE SITE TO INSPECT THE DEVICE. UPON INSPECTION, IT WAS FOUND THAT THE MID-SECTION OF THE BED FRAME WAS BENT. ADDITIONALLY, THE GAS SPRING AND BACKREST HINGE WERE BROKEN. THE BACKREST SECTION WAS DETACHED ON THE LEFT SIDE, CAUSING THE BED FRAME TO TILT TO THE LEFT. THIS TILT PREVENTED THE LEFT HEAD SIDE RAIL FROM BEING LOCKED IN THE RAISED POSITION. PHOTOGRAPHIC EVIDENCE OF DAMAGES WAS PROVIDED. DUE TO BENT MID-FRAME, THE BED IS TO BE SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21966009 ↗InjuryMar 17, 2025Use of Device Problem; Use of Device Problem
ARJO WAS NOTIFIED OF AN EVENT INVOLVING AN ENTERPRISE 9000X BED. IT WAS REPORTED THAT A BED EXIT ALARM DID NOT WORK PROPERLY, AND THE PATIENT FELL FROM THE BED. AS A RESULT OF THE FALL, THE PATIENT BROKE THEIR HIP.
Patient problems: Fall; Hip Fracture
MAUDE report 21617263 ↗InjuryMar 17, 2025Use of Device Problem; Use of Device Problem
ARJO WAS NOTIFIED OF AN EVENT INVOLVING AN ENTERPRISE 9000X BED. IT WAS REPORTED THAT A BED EXIT ALARM DID NOT WORK PROPERLY, AND THE PATIENT FELL FROM THE BED. AS A RESULT OF THE FALL, THE PATIENT BROKE THEIR HIP.
Patient problems: Fall; Hip Fracture
MAUDE report 21617260 ↗MalfunctionDec 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ARJO WAS INFORMED ABOUT BROKEN SIDE RAIL FROM ENTERPRISE 9000X BED. THE DEVICE WAS INSPECTED BY AN ARJO SERVICE TECHNICIAN. IT WAS CLARIFIED THAT SIDE RAIL LOWER ARM WAS RIPPED OFF FROM THE BED FRAME. IT WAS SUGGESTED BY THE ARJO SERVICE TECHNICIAN THAT THE SIDE RAIL WAS DAMAGED BY A MENTALLY ILL PATIENT. ARJO RECEIVED IN TOTAL 3 COMPLAINTS FROM THE SAME CUSTOMER WITH THE SAME MALFUNCTION (B)(6); 3007420694-2024-00314, (B)(6); 3007420694-2024-00315 AND (B)(6); 3007420694-2024-00321). THIS REPORT REFERS TO (B)(6); (3007420694-2024-00321).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20901128 ↗MalfunctionDec 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ARJO WAS INFORMED ABOUT BROKEN SIDE RAIL FROM ENTERPRISE 9000X BED. THE DEVICE WAS INSPECTED BY AN ARJO SERVICE TECHNICIAN. IT WAS CLARIFIED THAT SIDE RAIL LOWER ARM WAS RIPPED OFF FROM THE BED FRAME. IT WAS SUGGESTED BY THE ARJO SERVICE TECHNICIAN THAT THE SIDE RAIL WAS DAMAGED BY A MENTALLY ILL PATIENT. ARJO RECEIVED IN TOTAL 3 COMPLAINTS FROM THE SAME CUSTOMER WITH THE SAME MALFUNCTION (TW (B)(4) - 3007420694-2024-00314, TW (B)(4) AND TW (B)(4) - 3007420694-2024-00321). THIS REPORT REFERS TO TW (B)(4) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20901094 ↗MalfunctionDec 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ARJO WAS INFORMED ABOUT BROKEN SIDE RAIL FROM ENTERPRISE 9000X BED. THE DEVICE WAS INSPECTED BY AN ARJO SERVICE TECHNICIAN. IT WAS CLARIFIED THAT SIDE RAIL LOWER ARM WAS RIPPED OFF FROM THE BED FRAME. IT WAS SUGGESTED BY THE ARJO SERVICE TECHNICIAN THAT THE SIDE RAIL WAS DAMAGED BY A MENTALLY ILL PATIENT. ARJO RECEIVED IN TOTAL 3 COMPLAINTS FROM THE SAME CUSTOMER WITH THE SAME MALFUNCTION (TW(B)(4) , TW (B)(4) - 3007420694-2024-00315 AND TW (B)(4) - 3007420694-2024-00321). THIS REPORT REFERS TO TW (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20900969 ↗MalfunctionNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE SERVICE REPAIR, THE ARJO TECHNICIAN FOUND THAT THE HINGES WERE BROKEN AND THE BACKREST ACTUATOR WAS DETACHED FROM THE METAL FRAME. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20639311 ↗
Other Arjohuntleigh AB products
All Arjohuntleigh AB devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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