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

Model Number	KMCSUN
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inspection of the involved maxi move lift did not reveal any device failure that could contribute to the reported tipping.The functional test confirmed that the lift was operating correctly.The similar incident occurred twice in the same facility with the same facility staff and resident- another event is registered under manufacturer report no.9681684-2024-00076.The investigation revealed that pulling the sling during repositioning can disrupt the balance and stability of the lift.When the sling with the reisdent is pulled, the center of gravity shifts.If the force is strong enough, it can cause the lift to lose its stability and tip over.The instructions for use dedicated to maxi move (001.25060.En rev.19) warn: "do not attempt to move the lift by pulling or pushing on the mast, the jib, the spreader bar or the resident as this can cause the lift to topple over, and cause injuries.Always use the manoeuvring handle when displacing the lift." in summary, initial training was conducted to instruct staff on the correct use of the device to prevent similar incidents in the future.Additional training session is planned.Arjo device failed to meet its performance specification since the lift tipped over.The device was used to transfer the resident when the event occurred.The complaint decided to be reportable due to the lift tipping sideways.
Event or Problem Description
Following the reported information, the maxi move floor lift tipped sideways during the transfer of the resident to the wheelchair.This occurred when one of the two personal support workers (psws) pulled the sling with the resident to ensure his back was against the wheelchair¿s backrest, while the second psw was guiding the lift.One of the lift¿s legs was positioned under the wheelchair and another in front.The facility staff was not sure whether the brakes were locked at that moment or not.The resident was placed safely in the wheelchair.Two other psws assisted to prevent the lift from tipping over and helped to unhook the sling.No injury was claimed.

• 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: 20544231
• Report Number: 9681684-2024-00075
• Device Sequence Number: 18111019
• Product Code: FSA
• UDI-Device Identifier: 05055982766937
• UDI-Public: (01)05055982766937(11)240314
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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 Sex: Male