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

Model Number	9611AF101BCUSB
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the evaluation of the device, the arjo service technician found that the side rail did not stay in the locked position due to some liquid that entered the side rail locking mechanism.The facility staff said that this liquid looked like feeding tube medication.This caused the side rail pin to not slide out.The instruction how to lock the side rail is described in the enterprise 9000x instruction for use (746-591-en_13).There is a warning included: "make sure the locking mechanism is securely engaged when the side rails are raised." operation of the side rails should be checked daily, if the result of the test is unsatisfactory, the customer should contact arjo or approved service agent.From the above it seems that the side rail was malfunctioned.The side rail pin which allows to lock the side rail was stuck due to feeding tube medication which got into locking mechanism.When the patient leaned on the side rail, it opened.Arjo device failed to meet its performance specification since the side rail failed to stay in upright position, resulting in patient's fall.The device was used for a patient treatment when the failure occurred.This complaint is deemed reportable due to alleged patient's fall from the bed.
Event or Problem Description
Arjo was notified of an event involving an enterprise 9000x bed.It was reported that a patient leaned up against the bed siderail and that the latching mechanism failed.The patient fell out of bed onto the floor.No injuries were reported.

• 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: 19565544
• Report Number: 3007420694-2024-00155
• Device Sequence Number: 6948639
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190321
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/19/2024

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: 05/21/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2019
• 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