Based on the customer report, the supplied images and the information from the technician, we conclude that the root cause is that the internal lithium-ion battery was penetrated by a 30mm screw during the cart mounting process.The product risk evaluation for aview 2 advance was reviewed and the risk r230-01 adresses the risk of vesa mounting resulting in a battery fire.This incident did not result in any user or patient harm so there is no basis for changing the current severity and probability of r230- 01.There is an ongoing capa (ca-000810) in order to futher assesses and document the issue.We are currently in communication with fda officer from division dht3a/oht3 on remedial actions.
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