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

Model Number	KMCSUN-D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is distributed outside the us and no gudid information exists.During the system inspection conducted by the arjo representative, no malfunction of either the lift or the sling was identified that could have contributed to the event.The caregiver was unsure how the resident came out of the sling and hypothesized that the resident may have detached the sling clip.The resident became resistive during transfer, exhibiting behaviors such as kicking and pulling on the sling, which likely led to clip detachment.Maxi move instructions for use (001.25060.En) recommend using the crossed leg clips method for patients who are prone to kicking: ¿if the resident is prone to kicking off the leg clip, the crossed attachment of the leg clips shall be applied, which will prohibit the clip from being kicked off.¿ if this method was not employed, the likelihood of detachment would be further elevated.In summary, the most probable root cause of the incident could be related to the selected method of sling application.Due to limited information available, the root cause remains inconclusive.No deficiency was identified in the system (maxi move used with sling); it met its specifications.The system was used for patient transfer and therefore played a role in the incident.This complaint was deemed reportable due to the patient¿s fall.No serious injury was reported.
Event or Problem Description
The resident was being transferred from the bed to a shower chair using a maxi move lift and a sling.During the transfer, the resident became resistive, exhibiting behaviors such as kicking and pulling on the sling.The resident subsequently fell to the floor in the bedroom.The resident sustained a laceration on the back of the head, bruising to the right medial thigh, and facial bruising.The caregiver also sustained injuries, including a sprain to the right hand, wrist, and shoulder, as well as a left torso sprain.Additional clinical information indicates that the resident was treated with a glue stitch for the laceration, and the caregiver is currently on modified duties.

• 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: 23670103
• Report Number: 9681684-2025-00107
• Device Sequence Number: 18582284
• Product Code: FSA
• UDI-Device Identifier: 05055982766951
• UDI-Public: (01)05055982766951(11)241212
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/28/2025

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-D
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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 Age: 88 YR
• Patient Sex: Female
• Patient Weight: 55 KG