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

Model Number	KMCSUN
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Insufficient Information (4580)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is distributed outside the us and no gudid information exists.Process of gathering and analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.
Event or Problem Description
A caregiver tripped over a loose plastic cover located on the leg of a maxi move lift while walking across the lift base.As a result, the caregiver fell and sustained a knee injury.The caregiver did not attend the emergency department but subsequently sought medical evaluation, which included a radiology examination.No additional clinical information regarding the injury or treatment has been provided to date.No patient was present or involved at the time the reported issue occurred.
Additional Manufacturer Narrative
The plastic leg covers require slight upward force to detach and should not come off without resistance.The retaining edge at the end of the leg is intended to provide this resistance; if damaged, the cover may detach more easily.During inspection, the arjo technician confirmed that the cover could be partially removed and reattached.Replacing the cover did not change this behaviour, which is consistent with the product¿s design and does not represent a device malfunction.The incident occurred when the caregiver attempted to walk through the base of the patient lift, an area that is not intended to be used as a walking path during normal operation but rather to support and stabilize the device.The incident was primarily caused by the caregiver walking through the base area, which presents a foreseeable tripping hazard that cannot be attributed solely to the loose cover.According to the instructions for use (ifu, 001.25060.En rev.19, sep/2022), ¿care must be taken not to allow anything to stand in the way of the chassis¿ moving legs.¿ additionally, the ifu contains repeated warnings instructing users to keep both patient and attendant legs and feet clear of the lift structure: ¿ensure that the patient¿s and attendant¿s legs and feet are well clear of any parts of the lift.¿ in summary, the arjo product was directly involved with the reported incident, the caregiver tripped on a loose plastic leg cover located on the base of the lift while walking through the base area.The lift¿s base area is not intended to be used as a walking path and presents a foreseeable tripping hazard.No patient was present or involved at the time the reported issue occurred.Although the leg cover could be manually detached, this condition does not represent a device malfunction, and was not the primary cause of the event.
Event or Problem Description
A caregiver tripped over a loose plastic cover located on the leg of a maxi move lift while walking across the lift base.As a result, the caregiver fell and sustained a knee injury.The caregiver did not attend the emergency department but subsequently sought medical evaluation, which included a radiology examination; however, the results of this assessment are not known to arjo.We were informed that the caregiver has been off work and returned to work with slightly modified duties three days after the event.No additional clinical information regarding the injury or treatment has been provided to date.No patient was present or involved at the time the reported issue occurred.

• Brand Name: MAXI MOVE
• 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: 24399060
• Report Number: 9681684-2026-00010
• Device Sequence Number: 18217664
• Product Code: FSA
• UDI-Device Identifier: 05055982766937
• UDI-Public: (01)05055982766937(11)240306
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: KMCSUN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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