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

Model Number	9814DF101BCUSB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The technician reported that it is believed that the backrest of the bed was caught under a shelf mounted on the wall.When an attempt was made to raise the backrest, the obstruction prevented backrest movement, putting pressure on backrest hinges and causing them to break.In addition to hinges failure, technician reported broken gas spring and bent mid-frame.Backrest actuator was resting on metal bar, still attached to bed frame.Complaint and post-market surveillance data suggest that the gas spring failure, bent mid-frame, and hinge breaking in half were consequences of force being applied to elements of the bed.Based on the information received, it seems most likely that the backrest section was lifted without noticing that it was blocked by an obstacle.This resulted in damage to the bed parts.The instructions for use (ifu) for enterprise 9000x bed (746-591-en re.19) includes the following information relevant to the subject of this investigation: - "when the bed is operated, make sure that obstacles such as feet, oxygen bottles, bedside furniture or any other objects do not restrict its movement." to sum up, arjo device did not meet its specification since elements of the bed frame got damaged.The bed was used by a patient during the event.This complaint was assessed as reportable due to an allegation of backrest hinges failure during use with patient.
Event or Problem Description
Customer reported that backrest of the enterprise 9000x bed would not go up or down.At the time, bed was used by a patient.No injury was reported.Arjo technician visited the site to inspect the device.Upon inspection, it was found that the mid-section of the bed frame was bent.Additionally, the gas spring and backrest hinge were broken.The backrest section was detached on the left side, causing the bed frame to tilt to the left.This tilt prevented the left head side rail from being locked in the raised position.Photographic evidence of damages was provided.Due to bent mid-frame, the bed is to be scrapped.

• 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: 21966009
• Report Number: 3007420694-2025-00110
• Device Sequence Number: 15493927
• Product Code: FNL
• UDI-Device Identifier: 05055982755207
• UDI-Public: (01)05055982755207(11)220606
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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: 9814DF101BCUSB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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