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 Codes	Fall (1848); Hip Fracture (2349)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Arjo was notified of an event involving an enterprise 9000x bed.It was reported that a bed exit alarm did not work properly, and the patient fell from the bed.As a result of the fall, the patient broke their hip.

• 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
• MDR Report Key: 21617263
• Report Number: 1419652-2025-00014
• Device Sequence Number: 17814199
• Product Code: FNL
• UDI-Device Identifier: 05055982755207
• UDI-Public: (01)05055982755207(11)181212
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2025
• Report Date (Section F): 03/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 9814DF101BCUSB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2025
• Device Age: 7 YR
• Date Report to Manufacturer: 03/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/17/2025