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

Model Number	9611AF101BCUSB
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instruction how to lock the side rail is described in the enterprise 9000x instruction for use (746-591-en_12).There is a warning included: ¿make sure the locking mechanism is securely engaged when the split side rails are raised.¿ operation of the side rails should be checked daily.If the result of the test is unsatisfactory, the customer should contact arjo or an approved service agent.From the above, it seems that the side rail was malfunctioning.The side rail pin, which allows the side rail to lock, was not fully engaging due to internal debris or aged grease which got into the locking mechanism.When the patient leaned on the side rail, it opened.The patient fell from the arjo device and therefore, it played a role in the event.The involved system malfunctioned (side rail did not lock correctly) therefore the device did not meet its specification.The complaint was assessed as reportable due to the indication of the patient¿s fall.
Event or Problem Description
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.

• 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: 22892407
• Report Number: 3007420694-2025-00219
• Device Sequence Number: 5828232
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190425
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/26/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 9611AF101BCUSB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2019
• 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