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	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of post-market surveillance data revealed that the main factor that could lead to the side rail detachment might be related to an excessive force applied to the side rail.This is in line with the arjo service technician statement (the side rail separated from the cover due to consistent pressure against it) and side rail condition (screws were pulled out).The instruction for use (ifu 746-591-en_12) states that the caregiver should check operation of the side rails daily, and if the fault is found, arjo or an approved service agent should be contacted.Arjo device failed to meet its performance specification since the side rail panel detached partially.There was a patient on the bed when the event occurred.No injury was sustained.The complaint was assessed as reportable due to the partial side rail detachment.
Event or Problem Description
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.

• 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: 22392013
• Report Number: 3007420694-2025-00167
• Device Sequence Number: 8994212
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190412
• 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): 07/03/2025

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
• Device Model Number: 9611AF101BCUSB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2019
• 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