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

Model Number	9611AF101BCUSB
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Arjo was notified of an event involving the enterprise 9000x bed.It was indicated that the headboard of the bed moved unexpectedly (it raised without touching any buttons).No patient was involved in the event and no injuries were reported.
Additional Manufacturer Narrative
An arjo representative visited the customer to inspect the device.He indicated that the buttons on the control panels were worn and therefore, the defective parts were replaced.Based on the device inspection results and the post-market surveillance data, the most likely cause of the reported unintended bed movement might be related to worn buttons on the control panels.The involved bed was over 4 years old.Following the device history review, the control panels had not been replaced before, which may suggest that the buttons on the control panels could fail due to normal wear.The instructions for use for the enterprise 9000x (document number: (b)(4)) states the following: weekly "check that the patient controls, caregiver controls and attendant control panels operate correctly".To sum up, the bed did not meet its performance specifications due to unintended movement of the head section.The device was not used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation of an unintended movement of the bed.

• 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: 18569125
• Report Number: 3007420694-2024-00020
• Device Sequence Number: 8203797
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190419
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2024

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: 01/02/2024
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• 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