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

Model Number	9814DF101BCUSB
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The circumstances of the patient's fall could not be clarified based on the available information.According to the customer, the bed was in a low position, and the side rails were raised.The customer also stated that the patient was confused and attempted to exit the bed on their own.The device was taken out of service by the facility and subsequently inspected by an arjo technician.No malfunction was identified, and the device passed a quality control check following the claim.The customer's allegation regarding the bed exit alarm not working could not be confirmed.The instruction for use for enterprise 9000x bed (ifu 746-591-en) includes below information about patient fall risk: "to reduce the risk of injury due to falls, lower the bed to minimum height when the patient is unattended." ifu also states: "the patient movement detection function should be checked periodically for correct operation and before each new patient uses the bed." "before using patient movement detection, verify that the alarm can be easily heard by caregivers, e.G.At the nurse's station." the bed exit alarm detects patient movement but does not prevent a patient from leaving the bed and falling.The available information suggests that patient-related factors (confusion and an independent attempt to exit the bed) contributed to the fall.No device-related malfunction was identified.To sum up, the event occurred while the device was being used for patient care.The device met its specification, as no malfunction was identified.This complaint is reportable due to the allegation of the patient's fall.No injury was sustained.
Event or Problem Description
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.

• 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: 24243925
• Report Number: 3007420694-2026-00022
• Device Sequence Number: 13166208
• Product Code: FNL
• UDI-Device Identifier: 05055982755207
• UDI-Public: (01)05055982755207(11)210921
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: 9814DF101BCUSB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• 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: Female