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

Model Number	KMCEUN-D
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	01/01/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The information gathering process is ongoing.Results will be provided upon completion of the investigation.The date of the event (section b3) is the estimated date based on the information provided by the customer that the event occurred in january 2025.Unique identifier (udi) - section d4:(b)(4).The device is distributed outside the us and no gudid information exists.Evaluated internally by the customer.
Event or Problem Description
The event occurred in january when a patient was recovering after abdominal surgery.According to the customer, a nurse used the dps function to lower the spreader bar but allegedly stopped too late, causing the spreader bar to press against the patient's abdomen.The patient passed away 24 hours later.Currently, there is no information indicating any failures of the arjo device.The customer inspected the device internally after the event.
Additional Manufacturer Narrative
The date of event in section b3 was corrected as the year was incorrectly provided in the initial report.The investigation is still ongoing.The results will be provided in the next report.
Event or Problem Description
The event occurred in january 2024 (over a year before arjo was notified) when a patient was recovering after abdominal surgery.According to the customer, a nurse used the control button to lower the spreader bar but allegedly stopped ¿too late¿, causing the spreader bar to press against the patient's abdomen.The patient passed away 24 hours later, and the surgeon confirmed that this was a result of the event.
Additional Manufacturer Narrative
Following a reported incident involving the maxi move lift, the customer conducted an internal inspection of the device.No failure of the arjo device was identified.Although arjo was informed of the incident approximately one year after it occurred, an arjo technician visited the customer site to perform a thorough inspection of the device.The inspection confirmed that the lift was operating correctly, with no mechanical or functional failure detected.It remains unknown whether any repairs were performed by the customer between the incident and arjo¿s inspection.The product instructions for use (ifu) for maxi move (001.25060.En) states the following: ¿take care not to lower the spreader bar onto the patient to avoid injuries.¿ in the complaint at hand, the spreader bar was lowered onto the patient causing it to press on the abdomen.The maxi move lift is equipped with an anti-crush detection system, designed to automatically engage when the spreader bar encounters an obstruction.According to the ifu: ¿the system will engage, stop the motor and all downward movement will cease.If this occurs, release the jib 'down' button immediately and press the jib 'up' button to raise the jib until lift is clear.Then remove the obstruction.¿ no issues with the anti-crush feature were reported by the customer or identified during arjo¿s evaluation.When anti-crush senses the obstacle, it will stop lowering.As per the ifu, the caregiver then needs to raise the jib (mast) using a control button to remove the obstruction.It is unknown if and when the spreader bar was removed.To summarize, the arjo device used during the incident met the specifications.The lift was found to be fully functional, with no evidence of malfunction that could have contributed to the patient¿s death.The incident was attributed to a failure to follow the ifu, specifically the instruction to avoid lowering the spreader bar onto the patient.The complaint was classified as reportable due to the patient¿s death, which occurred following the application of pressure to the post-operative abdominal area by the spreader bar.This appears to be an isolated incident.

• 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: 21717740
• Report Number: 9681684-2025-00030
• Device Sequence Number: 4514811
• Product Code: FSA
• UDI-Device Identifier: 05055982763042
• UDI-Public: (01)05055982763042(11)210513
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

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: Health Professional
• Device Model Number: KMCEUN-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: 03/24/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/25/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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: Death
• Patient Sex: Unknown