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.Following a thorough investigation, no malfunction was identified with either the maxi move lift or the loop sling that could have caused the patient¿s fall.The most probable root cause is incorrect sling application.The information provided by the customer indicates that they intended to transfer the resident into a chair.The shoulder straps were attached using the yellow loops, and the leg straps were attached using the green loops.The sling used for patient's transfer has color-coded loops to help caregivers adjust the patient's posture.Each loop color represents a different length, and using them properly is essential for comfort and positioning.The passive loop sling instruction for use (ifu, 04.Sl.00-11en) provides comprehensive guidelines on how to correctly apply the sling, complemented by graphical illustrations for further clarification.Warning: ¿use the same loop length (loop colour) for the shoulder straps and the same length (loop colour) for the leg straps.¿ ¿first attach the shoulder loops, then attach the leg loops.¿ ¿do not cross the shoulder straps.¿ ¿cross the leg straps.Pull one strap through the other.¿ sum up, the incorrect sling application seems to be the most probable root cause.No deficiencies were identified in the lift or sling; both met their specifications.They were used as a system for patient transfer and therefore played a role in the incident.This complaint decided to be reportable due to the patient¿s fall.
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.

• 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: 22697192
• Report Number: 9681684-2025-00079
• Device Sequence Number: 8878903
• 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: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/04/2025
• Date Device Manufactured: 06/05/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 79 KG