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

Model Number	KMCSUN-D
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Following information reported, the maxi move passive floor lift tilted during operation by 2 personal support workers (psw).The maxi move got caught up in the side frame of the bed and raised the entire lift off the floor several inches.When the lift slid off the bed frame landed on the psw's foot.As a consequence, the psw sustained slight red marks on the right small toes (non serious injury).This event occurred during preparation of the lift to transfer the patient.
Additional Manufacturer Narrative
The device evaluation and testing performed by the field service technician did not reveal any device failure.During interview with the facility staff, it was determined that the way of product use contributed to the event.The upper cylinder caught on the side frame of bed and raised the entire lift off the floor.Then, the lift slid off the bed frame and landed on the psw's foot.The facility representative is aware of the cause of the lift tipping.It was discussed with director of care and safety and maintenance personnel during visit of arjo field service technician.The instructions for use for the maxi move passive floor lift (document number: (b)(4)) warns: - "before raising the mast make sure there is enough clearance above the maxi move to ensure the safety of the patient and the people around, and to avoid injuries." arjo device failed to meet its performance specification since the maxi move floor lift tilted.The device was was not used to transfer the patient.The complaint decided to be reportable due to the allegation of the maxi move tilting.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18359827
• Report Number: 9681684-2023-00087
• Device Sequence Number: 20813770
• Product Code: FSA
• UDI-Device Identifier: 05055982766951
• UDI-Public: (01)05055982766951(11)181215
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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: 11/23/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2018
• 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