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(b)(4).On (b)(6) 2018 arjo has become aware of an event which occurred in (b)(6) residence located in (b)(6) with the involvement of arjo system: maxi move passive floor lift and maa4100-xl passive clip sling.It was reported that during resident transfer from a bed to a wheelchair, during initial phase of the transfer (resident was being raised from the left side of the bed), the right leg sling clip detached from the lift spreader bar.It was reported that resident (male, (b)(6) years old, (b)(6) kg) fell from the sling towards the left side of the bed.As a consequence of the event the resident's left side of head hit the nightstand (located near the bed) and right knee hit the bedframe.One of the staff members absorbed part of residents fall then the second staff lowered him to ground.The resident was transferred to (b)(6) hospital, assessed and returned with pain medication less than 24 hours later.No fractures were identified.The resident sustained a hematoma to right knee and the left side of his head.The blister was applied on the knee.After the event the device was quarantined by the facility and subjected to technical inspection by arjo service technician.The lift inspection showed that one castor was not locking properly, no other malfunction was detected.Please note that castor malfunction did not cause nor contribute to the reported failure.The sling inspection showed that the clip had a very low resistance and the head supports were missing.The sling evaluation confirmed that the sling was manufactured in 2005.Additionally, facility director of care, advised that she had a discussion with both involved in the event care staff regarding the sling attachment process when securing clip slings to the spreader bar.Conclusion of that discussion was an agreement to organize a post-incident training for the customer facility staff.The passive clip sling is a product intended for assisted transfers of residents with limited ability to move.The product's instruction for use (ifu) is provided with each device and describes the methods of use.The ifu provides also pictographic guidance regarding proper clip attachment process.The document guides, step by step, through a proper sling application.It is important to make sure that the clip sling is attached securely before and during the lifting process.According to the ifu for slings ((b)(4)): "it is essential that slings, their attachment cords, their straps and attachment clips are carefully inspected before each and every use.If the sling, cords or straps are frayed or their clips damaged, the sling or attachment cord should be withdrawn from use immediately and replaced." always check that all the sling attachment clips are fully in position before and during the lifting cycle, and in tension as the patient's weight is gradually taken up" additionally ifu warns that "the expected operational life for fabric slings and fabric stretchers is approximately 2 years from date of manufacture.This life expectancy only applies if the slings and stretchers have been cleaned, maintained and inspected in accordance with the "arjo sling information" documents, the "operating and product care instructions" and the "preventive maintenance schedule".Please note that the sling has been used for approximately 13 years.Based on the product knowledge and a simulation, when the labeling is followed and the sling is placed in the correct way and the instructions of using the system are followed, it is very unlikely a patient drop or other adverse event during the transfer of the patient with the sling and lift will occur.A sling clip, once correctly attached and monitored to stay in place as the weight of the person in the sling is gradually taken up, as stated in the labeling, is locked in position with the weight of the patient.It cannot go downward as it is suspended on the clip attachment lug, and it cannot go upward because it is pulled down by the weight of the patient.When reviewing reportable complaints for maxi move registered during last 5 years with similar fault description (clip detachment), we have found a limited number of reportable complaints.Review of similar complaints reported in the past confirmed that this failure is only possible to occur when the labeling was not followed.To conclude, the system - clip sling and lift, was used for patient transfer and in that way contributed to the alleged event.The sling clip did not pass inspection after the event - the clip has low resistance, have missing head supports and have been in use for above 10 years, it means that the system did not meet its performance specification.We report this event to competent authority based on the potential of serious injury if the incident would to re-occurred.
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On (b)(6) 2018 arjo has become aware of an event which occurred in (b)(6) residence located in (b)(6) with the involvement of arjo system: maxi move passive floor lift and (b)(4)-xl passive clip sling.It was reported that during resident transfer from a bed to a wheelchair, during initial phase of the transfer (resident was being raised from the left side of the bed), the right leg sling clip detached from the lift spreader bar.It was reported that resident (male, (b)(6) years old, (b)(6) kg) fell from the sling towards the left side of the bed.As a consequence of the event the resident's left side of head hit the nightstand (located near the bed) and right knee hit the bedframe.One of the staff members absorbed part of residents fall then the second staff lowered him to ground.The resident was transferred to (b)(6) hospital, assessed and returned with pain medication less than 24 hours later.No fractures were identified.The resident sustained a hematoma to right knee and the left side of his head.The blister was applied on the knee.After the event the device was quarantined by the facility and subjected to technical inspection by arjo service technician.The lift inspection showed that one castor was not locking properly, no other malfunction was detected.Please note that castor malfunction did not cause nor contribute to the reported failure.The sling inspection showed that the clip had a very low resistance and the head supports were missing.The sling evaluation confirmed that the sling was manufactured in 2005.
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