Enterprise 9611AF101BCUSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 05055982755030), received between Aug 20, 2019 and Mar 3, 2026 — classified as 5 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (15 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  FOLLOWING THE INFORMATION RECEIVED THE HEAD SIDE RAIL WAS PARTIALLY DETACHED FROM THE ENTERPRISE 9000X BED FRAME (TWO OF FOUR SCREWS BECAME DETACHED). IT WAS INDICATED THAT THE USER PULLED STRONGLY ON THE SIDE RAIL TO MOVE THE BED. THERE WAS NO PATIENT IN THE BED AT THE TIME OF THE EVENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235050 ↗
• MalfunctionJun 19, 2024Device Fell; Device Fell

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING AN ENTERPRISE 9000X BED. IT WAS REPORTED THAT A PATIENT LEANED UP AGAINST THE BED SIDERAIL AND THAT THE LATCHING MECHANISM FAILED. THE PATIENT FELL OUT OF BED ONTO THE FLOOR. NO INJURIES WERE REPORTED.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565544 ↗
• MalfunctionJan 24, 2024Unintended Movement; Unintended Movement

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING THE ENTERPRISE 9000X BED. IT WAS INDICATED THAT THE HEADBOARD OF THE BED MOVED UNEXPECTEDLY (IT RAISED WITHOUT TOUCHING ANY BUTTONS). NO PATIENT WAS INVOLVED IN THE EVENT AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569125 ↗
• MalfunctionNov 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ARJO RECEIVED A CUSTOMER COMPLAINT FOR ENTERPRISE 9000X BED. FOLLOWING THE INFORMATION PROVIDED ENTERPRISE 9000X BED WAS FOUND WITH DAMAGED SIDE RAIL. BASED ON THE INFORMATION RECEIVED FROM AN ARJO SERVICE TECHNICIAN, THE SIDE RAIL DETACHED PARTIALLY FROM THE BED FRAME DUE TO A MISSING PIVOT PIN. NO PATIENT INVOLVEMENT WAS REPORTED. NO INJURIES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099614 ↗
• MalfunctionJun 30, 2023Unintended Movement; Unintended Movement

  FOLLOWING THE INFORMATION PROVIDED, THERE WAS AN INDICATION OF AN UNINTENDED MOVEMENT ON THE ENTERPRISE 9000X BED. IT WAS REPORTED THAT SIDE RAIL CONTROLS WERE NOT WORKING HOWEVER, THE HEAD SECTION OF THE BED RAISED ON ITS OWN AND AN ERROR CODE E300 WAS DISPLAYED ON THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239219 ↗
• MalfunctionJun 20, 2023Unintended Movement; Unintended Movement

  FOLLOWING THE INFORMATION PROVIDED, THERE WAS AN INDICATION OF AN UNINTENDED MOVEMENT ON THE ENTERPRISE 9000X BED. IT WAS REPORTED THAT THE BED ¿KEEPS ELEVATING UNCONTROLLABLY AND STOPS WORKING¿ AND THAT THE CODES E410 AND E300 WERE DISPLAYED ON THE BED. THERE WAS NO INDICATION OF A PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161351 ↗
• MalfunctionMay 24, 2023Unintended Movement; Unintended Movement

  ARJO WAS INFORMED ABOUT THE EVENT INVOLVING THE ENTERPRISE 9000X BED. IT WAS INDICATED THAT THE BED MOVED UNINTENDED. IT IS NOT KNOWN IF THE PATIENT WAS ON THE BED AT THE TIME OF THE EVENT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990323 ↗
• MalfunctionFeb 8, 2023Unintended Movement; Unintended Movement

  ARJO WAS INFORMED ABOUT THE INCIDENT INVOLVING THE ENTERPRISE 9000X BED. THE CUSTOMER REQUESTED ARJO FOR SERVICE REGARDING THE FAULTY ENTERPRISE 9000X BED AND DURING THE DEVICE INSPECTION PERFORMED BY AN ARJO SERVICE TECHNICIAN IT WAS FOUND THAT THE UPPER RIGHT BUTTON OF THE CONTROL PANEL ON THE ENTERPRISE 9000X WAS DEFECTIVE AND WHEN PRESSED, IT JAMMED AND THE BED WAS RAISING. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16320653 ↗
• MalfunctionOct 26, 2022Unintended Movement; Unintended Movement

  FOLLOWING THE INFORMATION PROVIDED THE CUSTOMER REPORTED THAT THE BED WAS DISPLAYING E300 ERROR CODE AND WAS MALFUNCTIONING. AS PER THE INFORMATION PROVIDED, THE BED BACKREST SECTION WENT UP BY ITSELF AND THEN THE E300 CODE WAS DISPLAYED (MEANING THAT THE CONTROL BUTTON WAS PRESSED CONTINUOUSLY FOR OVER 90 SECONDS), DISABLING ALL BED FUNCTIONS. THERE IS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED. THE EVALUATION REVEALED THAT THE BACKREST CONTROL BUTTON WAS STUCK IN PUSHED POSITION, WHICH FIRST GENERATED UNINTENDED MOVEMENT AND THEN RESULTED IN E300 ERROR CODE. THE TECHNICIAN REPAIRED THE BED BY REPLACING THE SIDE RAIL WITH BUILT-IN CONTROLLERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672283 ↗
• MalfunctionSep 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  FOLLOWING THE INFORMATION PROVIDED THE CUSTOMER COMPLAINED THAT THE UNIT NEEDED SERVICE. THE ARJO TECHNICIAN ATTENDED SITE TO EVALUATE THE BED AND DETERMINED THAT THE SIDE RAIL LOWER ARM WAS DETACHED FROM ITS MOUNTING POINTS. THERE IS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507581 ↗
• MalfunctionSep 14, 2022Unintended Movement; Unintended Movement

  FOLLOWING THE INFORMATION PROVIDED THE CUSTOMER REPORTED INTERMITTENT FUNCTIONING OF ONE OF THE CONTROL PANEL BUTTONS ON ENTERPRISE 9000X RIGHT BODY SIDE RAIL. UPON EVALUATION THE ARJO TECHNICIAN CONFIRMED THAT THE BUTTON ON THE CONTROL PANEL WAS FAULTY AND WHEN THE BUTTON WAS RELEASED, THE BED CONTINUED TO MOVE INTERMITTENTLY. THERE IS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15416705 ↗
• MalfunctionMay 27, 2022Unintended Movement; Unintended Movement

  FOLLOWING THE INFORMATION PROVIDED THE CUSTOMER COMPLAINED THAT THE BED WAS GOING UP AND DOWN ON ITS OWN. NO PATIENT WAS INVOLVED, NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520946 ↗
• MalfunctionApr 29, 2022Unintended Movement; Unintended Movement

  FOLLOWING THE INFORMATION PROVIDED THE BED WAS INTERMITTENTLY LOWERING UNINTENDED, WHEN THE BUTTON WAS PRESSED, THE BED DID NOT STOP MOVING ONCE THE BUTTON WAS RELEASED. THE ARJO ENGINEER ATTENDED THE BED FOR EVALUATION AND REPAIRED THE BED BY REPLACING THE SAFETY SIDE WITH THE BUILT-IN CONTROLLERS. NO PATIENT WAS INVOLVED, NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250314 ↗
• MalfunctionJul 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  FOLLOWING INFORMATION REPORTED BY (B)(6), THERE WAS A PROBLEM WITH ENTERPRISE 9000X. MORE DETAILS WERE NOT PROVIDED BY THE CUSTOMER. THE EVALUATION OF THE DEVICE PERFORMED BY AN ARJO TECHNICIAN REVEALED THAT THE SAFETY SIDE RAIL DETACHED FROM THE BED FRAME. THERE WAS NO INDICATION REGARDING PATIENT INVOLVEMENT. NO INJURY OR OTHER MEDICAL CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10238777 ↗
• InjuryJun 18, 2020Unintended Movement; Unintended Movement

  ON (B)(6) 2020 ARJO WAS INFORMED THAT THE BACKREST SECTION OF THE ENTERPRISE 9000X MOVED UNINTENDED WITHOUT ANY ACTIONS GIVEN BY THE USER. THERE WAS NO PATIENT ON THE BED WHEN THIS ISSUE OCCURRED AND NO INJURY WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10166984 ↗
• InjuryApr 3, 2020Unintended Movement; Unintended Movement

  FOLLOWING INFORMATION REPORTED BY (B)(6) IN THE US, THE UNINTENDED MOVEMENT OF THE BACKREST SECTION OF THE ENTERPRISE 9000X BED WAS OBSERVED. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9920104 ↗