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

Model Number	KMCLXN-D
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient fell while being transferred using a maxi move 3 lift.The patient was moving unpredictably in the sling, and one side of the sling became disconnected from the spreader bar, resulting in a fall and head injury.The patient was transported to the hospital for treatment.No product defects were found.All lift functions were tested and confirmed to be working properly.The sling showed no signs of damage.
Additional Manufacturer Narrative
The information gathering process is ongoing.Results will be provided upon completion of the investigation.
Additional Manufacturer Narrative
When the tension is present during the transfer, there is a downward force on the sling attachment points, ensuring the attachment points remain in the desired location on the spreader bar hooks.In the reported complaint there was an allegation that the patient was moving in the sling (¿pushed with one foot against the bed¿), which might affect the tension of the sling and lead to further detachment of one side of the sling from the lift spreader bar.The maxi move must always be operated by a trained caregiver and in accordance with the instructions outlined in the instructions for use (ifu) for maxi move.The ifu 001.25060.En stress step by step how to lift the person from a bed and caution to "always check that all the sling attachment clips are fully in position before and during the lifting cycle, and in tension as the patient's weight is gradually taken up." "check that all four points of the sling are securely connected before lifting." maxi move is dedicated for the passive patient who has no capacity to support himself and is not able to bear weight.It has been concluded that arjo's investigation corresponds to the customer's results.The patient's movements most likely caused the sling to become disconnected from the spreader bar when the sling was not under the tension due to patient¿s movement.No deficiencies were identified in the maxi move 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 from the sling.

• 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: 22183535
• Report Number: 9681684-2025-00051
• Device Sequence Number: 8588402
• Product Code: FSA
• UDI-Device Identifier: 05055982764971
• UDI-Public: (01)05055982764971(11)220620
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: KMCLXN-D
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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 Sex: Unknown