MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 440; LIFT, PATIENT, NON-AC-POWERED

Model Number	LE00000-AU
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Arjo was informed about the incident with the maxi sky 440 ceiling lift and easytrack fs installation system involvement.It was reported that the customer¿s staff transferred a patient from a bed to a powered wheelchair.After completing the transfer, the staff left the patient in the room.When the patient wanted to leave the room in the wheelchair, the easytrack fs frame partially fell forward twisting to the left.The patient managed to drive under the frame and left the room.No injury was reported as a consequence of the reported event.After the incident, the installation was inspected by an arjo service technician.The service technician observed that the lift attached to the track moved from one end to another due to frame collapse and that there were white marks on the installation track which came away when wiped.The technician placed the installation in the correct position and performed a function test.No problem occurred after the repair and the system was put back into service.
Additional Manufacturer Narrative
Arjo was informed about the incident with the maxi sky 440 ceiling lift and easytrack fs installation system involvement.It was reported that the customer¿s staff transferred a patient from a bed to a powered wheelchair.After completing the transfer, the staff left the patient in the room.When the patient wanted to leave the room in the wheelchair, the easytrack fs frame partially fell forward twisting to the left.The patient managed to drive under the frame and left the room.No injury was reported as a consequence of the reported event.After the incident, the installation was inspected by an arjo service technician.The service technician observed that the lift attached to the track moved from one end to another due to frame collapse and that there were white marks on the installation track which came away when wiped.The technician placed the installation in the correct position and performed a function test.No problem occurred after the repair and the system was put back into service.During the client's visit, the technician spoke with the patient involved in the incident and took photos showing the reported problem.According to the patient, the wheelchair was in such a position after completing the transfer that when she wanted to drive it out of the room, she drove it onto the right base of the installation.As a result, the frame twisted to the left, causing the entire installation to tilt forward.Based on the description of the event that occurred, we are unable to determine whether the interaction between the wheelchair on which the patient was located and the base of the installation could have resulted in the structure falling over.The instructions for use for the easy track fs (document number: 001.17300.En) instructs the user on how to make sure the installation is installed correctly through the following cautions: ¿caution: make sure both posts are correctly inserted into each base.¿ ¿caution: make sure the main hooks are well engaged.¿ ¿caution: never extend the post to allow the track to be in contact with the ceiling (.).¿ the document also indicates to: "lock the clamping collars on both posts to prevent the posts from extending by themselves.When the collars are locked, no red mark should be visible" and to: "adjust the levellers on each base to stabilize the bases.When adjusting the levellers, make sure the central gliders are in contact with the floor." the "care and maintenance" section of instructions for use for easytrack fs also contains the following information: "points to be inspected by user: before every use: make sure that bases are properly adjusted".Based on the information obtained from the service technician, the installation was installed on july 11, 2022, and the last inspection took place on august 10, 2022.No abnormalities in the operation of the device were found at that time.Based on the information obtained during the course of this investigation, we are unable to determine the exact root cause of the reported malfunction.To sum up, the maxi sky 440 ceiling lift and the easytrack fs installation were used as a system for the patient transfer when the installation frame collapsed and from that perspective, the system did not meet its performance specification.The complaint was decided to be reported to competent authorities due to the indication that the easytrack fs frame fell.No injury was sustained.

• Brand Name: MAXI SKY 440
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15486582
• Report Number: 9681684-2022-00064
• Device Sequence Number: 5256153
• Product Code: FSA
• UDI-Device Identifier: 05055982795319
• UDI-Public: (01)05055982795319(11)220119
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 09/22/2022

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: LE00000-AU
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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: Female