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.
Additional Manufacturer Narrative
The device is distributed outside the us and no gudid information exists.Following the event, the lift and sling (model maa4100m-l, serial number (b)(6)) were inspected by an arjo technician.No malfunctions were identified, and all functions were found to be operating as intended.Based on the information collected, the resident was a full quadriplegic, non-verbal, and had no muscle tone, although occasional spasms had been reported.The investigation is ongoing.Results of the analysis will be provided to the final report.

• 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 ; +48()883337089
• MDR Report Key: 50943290
• Report Number: 9681684-2026-00082
• Device Sequence Number: 9499123
• Product Code: FSA
• UDI-Device Identifier: 05055982766937
• 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: Manufacturer
• Report Source: Foreign
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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: Death
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 162 LB