We are be informed one mdr from customer in (b)(6) 2016.The medical device involved in the incident is a?cruiser x4 wheelchair, item: cx418adda-sf.Serial number (b)(4)according to the description and survey, the end user was attempting to move from the bed to the wheelchair, the hight adjustable armrest was not locked, so the armrest fell off, causing the patient to fall.We checked the manual of cruiser x4 chair and found it doesn't have usage instruction for hight adjustable armrest.We sent the test report to customer.According to serial number (b)(4), we checked the po number (b)(4) and lot no.Ak2015110083, there are totally 10pcs cx418adda-sf in this order.And we also checked the three batches before this order.We checked the sales records, no similar complaints.We communicate with customer to do some survey, from the pictures they offered, we cannot find any defects.The sales people told customer about the improvements of manual, add any usage instruction for hight adjustable armrest.The customer agree with the solution.
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