MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 2; LIFT, PATIENT, NON-AC-POWERED

Model Number	MS115
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.The follow-up will be provided within next report.
Event or Problem Description
Arjo was informed about the incident involving the maxi sky 2 ceiling lift.Following the information provided, when a patient was being re-positioned using a lift, the device made abnormal noises and dropped the patient into bed several inches.The patient did not sustain any injury.After the event an arjo representative visited the customer to conduct the device inspection.The service technician informed that the most likely cause of the reported incident was related to the lift's transmission assembly malfunction.
Additional Manufacturer Narrative
The process of collecting and analyzing information is ongoing.The follow-up will be provided within next report.
Additional Manufacturer Narrative
The defective components were returned to the manufacturer on 15 mar 2023 for the further invstigation.The results of the analysis will be provided upon completion of the manufacturer evaluation.
Additional Manufacturer Narrative
It was decided to return the defective components for the investigation to the manufacturer.The shipment is in process.
Additional Manufacturer Narrative
The ceiling lift was returned to the manufacturer for a detailed investigation.The visual inspection revealed that the motor mounting screws were loose, causing vibration of the motor.This slight movement may have caused an incomplete disruption between the shaft of the motor and the first stage gear as evidenced by traces of white flake and abnormal noise reported.The most possible cause was under-tightened screws.During the device evaluation, also the emergency brake (a feature that would stop the sudden lowering of the strap) was tested and was found fully functional.Due to limited information provided by the customer, it was not possible to determine whether the emergency brake was engaged at the time of the event.To summarize it up, the malfunction of the device occurred during transfer of the patient.As per the information gathered, the lifting strap unwound itself so maxi sky 2 ceiling lift was not up to manufacturer¿s specification.The complaint was deemed reportable due to the allegation of unintended, fast dropping of a patient during a transfer.

• 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: 16041229
• Report Number: 9681684-2022-00084
• Device Sequence Number: 5237618
• Product Code: FSA
• UDI-Device Identifier: 05056097367934
• UDI-Public: (01)05056097367934(11)200622
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/16/2023

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: MS115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 12/05/2022; 12/05/2022; 12/05/2022; 08/07/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 01/16/2023; 02/15/2023; 03/17/2023; 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2020
• 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
• Patient Weight: 249 KG