MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 440; LIFT, PATIENT, NON-AC-POWERED

Model Number	LE00000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Fall (1848)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The maxi sky 440 ceiling lift detached and fell together with the patient.No injury was claimed.The device inspection revealed that the reacher's hook that allows to connect the ceiling lift to the track was bent.
Additional Manufacturer Narrative
The investigation ongoing.The results will be provided upon conclusions of the investigation.
Additional Manufacturer Narrative
The process of gathering information is still ongoing.The conclusions will be provided when the investigation is completed.The date of the event (section b3) was estimated based on the awareness date.The reacher accessory involved in the event was manufactured by the third-party company- agecinox and distributed by arjo.
Additional Manufacturer Narrative
The review of complaints revealed that this is the second complaint of the bent reacher's hook.The reacher from the previous complaint was returned to the manufacturer (factory in magog) for evaluation.The ceiling lift detachment was recreated only under specific conditions when the reacher was used to intentionally detach the ceiling lift (the reacher used to push the reacher's hook out of the trolley).Following the manufacturer's analysis, a high load at a specific angle is required to deform the reacher's hook, which is unlikely to occur during normal use as described in the instructions for use.The reacher was replaced.To sum up, based on all information gathered and the testing performed by the manufacturer, the exact cause of the claimed ceiling lift detachment could not be determined.The ceiling lift failed to meet its performance specification since it detached.The device was used for a patient transfer when the failure occurred.
Event or Problem Description
The maxi sky 440 ceiling lift detached and fell together with the patient.No injury was claimed.The maxi sky 440 portable ceiling lift may be attached to the rail using the reacher.This accessory is composed of the reacher rod and hook, connected to each other by a magnet.To connect the ceiling lift to the rail, the reacher's hook needs to be attached to the ceiling lift carabiner and connected to the rail trolley.The inspection was performed by arjo technician in presence of director and caregivers.It revealed that the reacher's hook was bent.No other failure was observed.The load test at 200 kg was performed and the ceiling lift operated correctly.

• Brand Name: MAXI SKY 440
• 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: 20890936
• Report Number: 9681684-2024-00088
• Device Sequence Number: 15686863
• Product Code: FSA
• UDI-Device Identifier: 05055982795319
• UDI-Public: (01)05055982795319(11)221025
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/05/2025

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
• Device Model Number: LE00000
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/08/2025; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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