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

Model Number	KMCSUN-D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided upon investigation conclusion.
Event or Problem Description
It was reportd that during patient transfer from a bed to wheelchair the left shoulder clip detached.As a consequence of the event the patient fell out from the device.Collecting of the information is ongoing.The patient sustained head injury which required 4 stitches.
Additional Manufacturer Narrative
Collecting of the information is ongoing.Additional information will be provided upon investigation conclusion.
Additional Manufacturer Narrative
Arjo was informed about an event involving arjo passive maxi move lift and sling.A patient was transferred from a bed to a wheelchair (in a sitting position) with the assistance of 2 caregivers.In the middle of a transfer (approximately a 1-meter distance), the left shoulder clip detached from the device spreader bar causing the resident to slide and fall on the left side.As a consequence of the event, the patient sustained a head injury that required 4 stitches.Upon inspection, both the lift and clip of sling were in good working condition.During the interview, the customer believed that the clip detached due to the resident being tall and when being transferred from bed to chair the bed was at a high position and the resident pushed off the bed with his foot resulting in the clip disengaging and resident falling.Based on the facts that were provided by the customer, it appears to be very unlikely that the clip was partially attached to the spreader bar if the patient was fully suspended at the time of the event.On the latest generation of maxi move, the ¿mushroom shape¿ at the end of the lug does not only make sure that the clip cannot slide off; it also makes sure that the clip is fully on (the clip cannot be partially inserted, it is either ¿on¿ or ¿off¿).Therefore, when a patient is fully suspended, this suggests that the clips are correctly attached since the straps that connect the clips to the body of the sling are under tension by the weight of the person in the sling lifted.In this case, only a force in the opposite direction greater than the one applied by the gravity of the person's weight would be required to pull out a clip under tension.The tall patient in the sitting position pushing off the bed with his foot might have generated this force required to detach the clip.According to the procedures provided in the instruction for use of the passive clip sling (04.Sc.00): ¿warning: to avoid injury, always assess the patient prior to use.¿ ¿warning: to avoid the resident from falling, make sure that the sling attachments are attached securely before and during the lifting process.¿ ¿at any time, if the resident becomes agitated, stop transferring/transporting and safely lower the patient.¿ according to the procedures provided in the instruction for use of the maxi move (001.25060): ¿warning: patients with spasms can be lifted, but great care should be taken to support the patient¿s legs to prevent fall risk and injuries.¿ following all of the information gathered, the patient¿s movement may have caused the detachment of the clip, where patient shall have been assessed prior use.Patient¿s legs should have been supported and the transfer stopped and the patient safely lowered when the resident became agitated.The most likely root cause then is considered the caregiver not following the ifu.To sum up, the arjo floor lift and clip sling were used as a system during the patient transfer.The clip detached from the lift spreader bar and from that perspective system did not meet its performance specification.We decided to report this complaint to the competent authorities due to the clip detachment during use.
Additional Manufacturer Narrative
Additional information will be provided upon investigation conclusion.

• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15454939
• Report Number: 9681684-2022-00062
• Device Sequence Number: 20522561
• Product Code: FSA
• UDI-Device Identifier: 05055982766951
• UDI-Public: (01)05055982766951(11)200526
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 08/26/2022; 08/26/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/21/2022; 11/25/2022; 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2020
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 85 KG