MAUDE Adverse Event Report: ArjoHuntleigh Magog inc. Maxi Sky 2; Lift, Patient, Non-Ac-Powered

Model Number	MS110-01-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer representative contacted arjo and reported that the spreader bar had detached from the maxi sky 2 lift.No patient was involved at the time of the event, and no injuries were reported.
Additional Manufacturer Narrative
The device is distributed outside the us and no gudid information exists.The device, including the spreader bar, was visually inspected by an arjo representative.The overall condition of the device was found to be good, and no malfunction, damage, or deficiency of the spreader bar connect mechanism.(quick-connect) was identified that could have contributed to the reported event.The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

• Brand Name: Maxi Sky 2
• 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 ; +48()883337089
• MDR Report Key: 50771021
• Report Number: 9681684-2026-00079
• Device Sequence Number: 21204389
• Product Code: FSA
• UDI-Device Identifier: 05056097356815
• UDI-Public: (01)05056097356815(11)251217
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: MS110-01-02
• 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: 08/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2025
• 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