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

Model Number	KMCEUN-D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	01/01/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The date of the event (section b3) is the estimated date based on the information provided by the customer that the event occurred in (b)(6) 2025.Unique identifier (udi) - section d4: ((b)(4).The device is distributed outside the us and no gudid information exists.
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.

• 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
• MDR Report Key: 21717736
• Report Number: 1419652-2025-00018
• Device Sequence Number: 19962047
• 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: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2025
• Report Date (Section F): 03/28/2025

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 the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/24/2025
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/28/2025