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

Model Number	9611AF101BCUSB
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Following the information received the head side rail was partially detached from the enterprise 9000x bed frame (two of four screws became detached).It was indicated that the user pulled strongly on the side rail to move the bed.There was no patient in the bed at the time of the event.No injury was reported.
Additional Manufacturer Narrative
Process of analyzing information is ongoing.Additional information will be provided upon investigation conclusion.
Additional Manufacturer Narrative
Arjo was notified of an incident involving the enterprise 9000x bed.Based on the information received, the side rail was partially detached from the bed frame (two of the four screws had been detached).It was indicated that the user pulled on the side rail to move the bed.The problem occurred while the bed was being transported.There was no patient in the bed at the time of the event.No injuries were reported.The bed was repaired by an arjo service technician.The faulty part was replaced.The review of post-market surveillance data revealed that the main factor which could lead to the side rail detachment might be related to an excessive force applied to the side rail.This is in line with the information received and the bed frame condition, confirmed by the arjo representative¿s evaluation.Upon interviewing the facility personnel, it was stated that the damage occurred while one of the staff members wanted to move the bed by pulling on the side rail.According to enterprise 9000x instructions for use (ifu, 746-591 rev.11): "hold the head board or foot board when pushing or pulling the bed; do not hold the side rails or any attached accessories".Arjo device failed to meet its performance specification since the side rail panel detached partially from the side rail mechanism.There was no allegation of any patient involvement.The complaint decided to be reportable due to the side rail partial detachment.

• 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: 20235050
• Report Number: 3007420694-2024-00238
• Device Sequence Number: 8089513
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190304
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/11/2024

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: Other
• Device Model Number: 9611AF101BCUSB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2019
• 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