The customer reported problem was confirmed.The device was repaired, passed all require testing and specifications and released back to the customer.Based on the file review, no further escalation is required per (b)(4) complaint escalations, infusion products global customer support operations.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.The customer stated that there is no patient involvement.
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Broken/damaged label- damaged, internal frame- damaged/cracked, flange gripper- damaged/cracked, claw- stuck/sticking, pca door- hinge damaged, linear potentiometer- faulty, case front- damaged/cracked case rear- damaged/cracked, barrel clamp assy- damaged/cracked, handle- damaged/cracked carriage assy- tube drive bent, flange gripper- wiper seal damaged.There was no patient involvement.(b)(4).Please request approval for if additional repairs are required.
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