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	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the service repair, the arjo technician found that the hinges were broken and the backrest actuator was detached from the metal frame and bed gas spring was not working.No injury was reported.According to the received complaint, several components have been damaged - the hinges, the actuator, and the gas spring.Each of these components is responsible for adjusting the position of the backrest.When the hinges break (as they are the weakest point), it can lead to further malfunctions, such as mechanical damage to the gas spring and the actuator.As a result, the backrest may collapse.The conducted analysis showed that the most probable cause of such damage is backrest blockage by an obstacle (e.G., windowsill, room furnishings).Then, the force acting first on the hinges and then on the other components leads to their damage and the lowering of the backrest.The instructions for use (ifu; 746-591-en) include information and warnings about proper usage of the equipment, including: ¿when the bed is operated, make sure that obstacles such as feet, oxygen bottles, bedside furniture, or any other obstacles do not restrict its movement.¿ the hypothesis mentioned above could not be confirmed as the customer did not provide information concerning the circumstances of the damage.Several attempts to gather detailed information were unsuccessful.In summary, it is not known exactly how the actuator detached but the investigation indicates that an operational problem cannot be ruled out.The actuator was found to be detached and from that perspective, the device did not meet performance specifications.It is unknown if the device was in use when the issue occurred.The complaint was assessed as reportable due to allegation that backrest section collapse due to actuator detachment.No injury was claimed.
Additional Manufacturer Narrative
Additional information will be provided upon investigation conclusion.
Event or Problem Description
During the service repair, the arjo technician found that the hinges were broken and the backrest actuator was detached from the metal frame.No injury was 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: 20639311
• Report Number: 3007420694-2024-00283
• Device Sequence Number: 18000249
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190507
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/25/2024
• Date Device Manufactured: 05/07/2019
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown