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

Model Number	9814DF101BCUSB
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Process of analyzing information is ongoing.Additional information will be provided upon investigation conclusion.
Event or Problem Description
It was reported that the enterprise 9000x bed was stuck in the trendelenburg position with a patient.It was indicated that there was no power in the side rail.The patient was safely removed from the bed and placed in a chair.No injuries were reported.The bed was swapped out.
Additional Manufacturer Narrative
The device was evaluated by an arjo technician.The issue was related to a power supply failure.Process of analyzing information is ongoing.Additional information will be provided upon investigation conclusion.
Additional Manufacturer Narrative
It was reported that the enterprise 9000x bed was stuck in the trendelenburg position with a patient.The patient was safely removed from the bed and placed in a chair.No injuries were reported.Based on the information received and the results of the device inspection, it appears that the bed frame being stuck in the trendelenburg position could be related to the faulty control box (cu20), the power supply and faulty internal wiring in the head's right side rail.Following the results of the device inspection, it appears that there was an electrical failure (e.G.An electrical short) in the device.However, it was not possible to confirm this based on the information gathered during the course of the investigation.Therefore, the exact cause of the observed malfunctions could not be determined.According to the enterprise 9000x instruction for use (ifu, 746-591-en_18): -¿carry out a full test of all electrical bed positioning functions (backrest, height, tilt, etc.)¿ weekly.The arjo device failed to meet its specification due to found malfunctions.The complaint was deemed reportable due to the bed being stuck in the trendelenburg position with the patient.

• 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: 20074000
• Report Number: 3007420694-2024-00215
• Device Sequence Number: 3034933
• Product Code: FNL
• UDI-Device Identifier: 05055982755207
• UDI-Public: (01)05055982755207(11)180104
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2024

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
• Operator of Device: Health Professional
• Device Model Number: 9814DF101BCUSB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/25/2024; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2018
• 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