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	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the on-site visit, the arjo technician noticed a note left on the enterprise 9000x bed saying that the bed was going up and down on its own.The bed was left in the storage room.There was no indication of patient involvement, and no injury was sustained.
Additional Manufacturer Narrative
The technician suspected a stuck button on the side rail and performed a full functional check, including testing all control buttons.No malfunction was found, and the issue could not be reproduced.The technician performed a bed reset, and it was operated as intended.The customer's allegation was not confirmed.The instruction for use for enterprise 9000x (746-591-en) recommends using "the function lockout on the attendant control panel to prevent unintended movement in situations where objects may press against the patient's controls".While no fault was found and the issue could not be reproduced, the incident may have been caused by external mechanical interference with the control panel.However, the hypothesis that the issue was caused by accidental activation of the controls due to external mechanical interference could not be confirmed.The arjo device did not fail a specification since no malfunction could have contributed to the alleged movement of the bed.There was no indication of a patient involvement.No injury was sustained.The complaint was deemed reportable due to the allegation of unintended bed movement (the bed was going up and down on its own).

• 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: 22848284
• Report Number: 3007420694-2025-00223
• Device Sequence Number: 8421833
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190306
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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: 07/28/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2019
• 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