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 Code	Bone Fracture(s) (1870)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4:the device is distributed outside the us and no gudid information exists.
Event or Problem Description
The resident was being transferred using a maxi move when they fell through the sling.The resident sustained a pelvic fracture.No malfunction was identified with either the maxi move lift or the loop sling that could have caused the patient¿s fall.

• 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: 22697191
• Report Number: 1419652-2025-00048
• Device Sequence Number: 8878902
• Product Code: FSA
• UDI-Device Identifier: 05055982766937
• UDI-Public: (01)05055982766937(11)240605
• 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: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/04/2025
• Report Date (Section F): 08/04/2025

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/28/2025
• Device Age: 1 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 79 KG
• Date Report Sent to FDA: 08/04/2025