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(b)(4).The customer was visited by the arjohuntleigh representative to perform interview and initial device evaluation, the following information were obtained: the patient was not suited for use with the sara 3000 active floor lift because at the time of incident the resident was not bearing her weight, in the incident was involved over 13 years old sara 3000, the lift and the sling were serviced by 3rd party company - (b)(4), the lift and the sling were modified by customer and are not met to manufacturer's specification.Additional information will be provided upon conclusion of the investigation.
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On (b)(6) 2017, an arjohuntleigh representative was informed about an incident related to sara 3000 active floor lift.The customer reported that the resident fell out of the device.As a consequence of the event, the resident's shoulder was broken.The injury required hospitalization.
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On 15th dec 2017, an arjohuntleigh representative was informed about an incident related to the sara 3000 active floor lift.The issue occurred in the (b)(6) nursing home located in (b)(6).Following the complaint's description, the resident fell out of the device.As a consequence of the event, the resident's shoulder was broken.The injured required hospitalization.The inspection of the involved active floor lift and the sling was performed by the arjohuntleigh representative the same day.The system was identified as sara 3000 with serial number (b)(4).The device was manufactured in 2004 and was in use for over 13 years.During the device examination, it was observed that the system was not according to the manufacturer's specification.It was established that the customer modified the floor lift years ago to lift the residents who were not able to keep their body weight by adding to sling a sheep cover, padlock and screws which allowed to tighten the sling clips to the sara 3000.It needs to be emphasized that according to the warning included in the instruction for use (ifu, kkx81010 rev.1 from jun 2003) "only arjo designated spare parts should be used." it was also established that the lift was not serviced by arjohuntleigh, but by the 3rd part company - (b)(4).Please also note, that the sara 3000 device involved in the event is an active resident lift.This means that the resident shall have an active participation in the transfer process - from raising the resident to the standing position, up to the transfer with the lift.In other words, the intended user group as indicated in the device labeling, is to be mentally and physically capable of at least partial standing capability and stability.In accordance to the information provided by the involved customer facility staff, at the time of incident the resident was not bearing her weight so she was not suitable to use this kind of active lift.As per ifu, the professional patient assessment should be carried out by a qualified nurse or therapist, before commencing the lifting process.Based on the above analysis, the unauthorized modifications of the sara 3000 lift and incorrect patient assessment were found to be a cause of the reported incident.If the caregiver follows every guideline given in the device lift ifu, there is a very low possibility of any potentially risky situation to occur.When reviewing the reportable events for sara 3000 and similar active lifts, we have found a number of cases related to the events which occurred when the user is not following the instruction for use.In summary, the device was being used at the time of the event and played a role in the reported incident.The device was not according to the manufacturer's specification because the unauthorized modifications of the sara 3000 lift were performed by the customer.During visit at the customer facility, recommended to exclude the device from use.We report this event to competent authority because the adverse event occurred.
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