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

Model Number	9611AF101BCUSB
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The circumstances under which the damage occurred are unknown.A review of post-market surveillance data showed that excessive external force applied to the side rail is the most common factor associated with similar detachments.This is consistent with the observed condition of the side rail in this case and aligns with the technician¿s statement suggesting that ¿it looks like they pushed it into something, causing it to break completely¿.The instruction for use for enterprise 9000x (ifu 746-591-en) states that the caregiver should check the operation of the side rails daily, and contact arjo or an approved service agent if a fault is identified.The device did not meet its performance specifications due to the confirmed malfunction.The device was not in use for patient care at the time of the event, and no injury was reported.The complaint was assessed as reportable due to the detachment of the side rail.
Event or Problem Description
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.

• 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: 24494665
• Report Number: 3007420694-2026-00027
• Device Sequence Number: 20106743
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190509
• 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
• Report Date (Section B): 03/03/2026

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: 9611AF101BCUSB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2019
• 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