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	01/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the maxi sky 2 ceiling lift (document number: (b)(4)) instructs the user how to attach the spreader bar to quick-connect attachment properly: align the spreader bar quick-connect latch to the hook.Insert the hook into the quick-connect.Move the spreader bar to engage the hook into the pivot.Rotate the spreader bar into position.Make sure that the quick-connect latch is closed.Do not operate the lift if the latch remains open (¿)¿.Additionally, the document in the 'preparation - actions before every use' section instructs the user to: "always ensure that the daily maintenance is carried out before using the lift paying special attention to the following elements: (.) make sure all attachments are properly secured, and that all the quick-connect components (cover and latch) are present.' to conclude, the maxi sky 2 ceiling lift was prepared for the resident transfer when the device's spreader bar disconnected from the lifting strap and from that perspective the device did not meet its performance specifications.The complaint was decided to be reportable due to an indication of spreader bar detachment.No injury was sustained.
Event or Problem Description
Following the information reported, the maxi sky 2 spreader bar detached during the preparation of the lift for patient transfer (during the lowering of the lift).As a consequence, the spreader bar fell on the resident, but its weight was held by the staff which prevented an impact.No injury was reported.After the event, an arjo representative conducted the device inspection at the customer's site.According to the service technician, the ceiling lift was operating correctly and the spreader bar quick-connect attachment components (cover and latch) had no signs of damage.

• 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 ; 883337089
• MDR Report Key: 16450987
• Report Number: 9681684-2023-00017
• Device Sequence Number: 5599382
• Product Code: FSA
• UDI-Device Identifier: 05056097356815
• UDI-Public: (01)05056097356815(11)210205
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2023

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: MS110-01-02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 73 KG