MAUDE Adverse Event Report: ArjoHuntleigh Magog inc. Maxi Move; Lift, Patient, Non-Ac-Powered

Model Number	KMCSUN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879); Hematoma (1884)
Date of Event	09/04/2026
Type of Reportable Event	Death
Event or Problem Description
Based on information received from the customer (the executive director), during a transfer using a maxi move lift and clip sling, the right leg clip became detached, resulting in the resident falling from the sling and striking their head.A hematoma was identified during the initial assessment, and the resident was transferred to the hospital for further evaluation.The resident passed away the following day.The reported cause of death was intracranial bleeding.The customer report indicated a possible right leg spasm at the time of the incident.Following the event, the lift and sling were inspected by an arjo technician.No malfunctions were identified, and all functions were found to be operating as intended.

• 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
• MDR Report Key: 50943292
• Report Number: 1419652-2026-00118
• Device Sequence Number: 18516399
• Product Code: FSA
• UDI-Device Identifier: 05055982766937
• UDI-Public: (01)05055982766937(11)231127
• 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): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: KMCSUN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 162 LB
• Date Report Sent to FDA: 09/30/2026