MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 9000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	9611AF101BCUSB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Process of collecting and analyzing information is ongoing.Additional information will be provided upon investigation conclusion.
Event or Problem Description
The customer reported that the bed backrest function was inoperative on the enterprise 9000x bed.No injury was sustained.During the bed evaluation, an arjo technician found that the backrest actuator and dampener failed, and the backrest inner hinge was broken.
Additional Manufacturer Narrative
Date received by manufacturer was corrected.
Additional Manufacturer Narrative
The hinges are located at the left and right side of the bed and allow regulation of the angle of the backrest and knee section.When the hinge became loose or damage and subsequently disconnects, a mechanical damage of gas spring (backrest damper) as well as backrest actuator may occur.The symptom of such failure is the collapse of the backrest section.The exact circumstances of the event remain unknown.No photographs or additional evidence showing the condition of the bed at the time of the failure were provided, which prevents a full assessment of the damage and limits the ability to determine whether any external factors (such as impacts, obstacles, or excessive force during movement) contributed to the malfunction.Therefore, a definitive root cause cannot be established.To sum up, the arjo device did not meet its specifications since components were found to be damaged.The patient was on the bed at the time of the event.No injury was sustained.This complaint was assessed as reportable due to an allegation of backrest hinge failure during patient use.Incident description was updated.
Event or Problem Description
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.

• Brand Name: ENTERPRISE 9000X
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 24091199
• Report Number: 3007420694-2026-00009
• Device Sequence Number: 21392141
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190506
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9611AF101BCUSB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2025
• Supplement Date Received by Manufacturer: Not provided; 12/19/2025
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/06/2026; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown