(b)(4).The device was not returned to physio-control.A third-party service agent evaluated the customer's device and verified the reported issue.A pin had broken off from the connector of the accessory hard paddles assembly, which caused the device to be unable to charge defibrillation therapy.The customer was advised to replace their hard paddles assembly and after performing some unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.Device not evaluated by manufacturer.
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A third-party service agent contacted physio-control to report that during the initial evaluation of their customer's device, it was observed that a pin had broken off from the connector of their accessory hard paddles assembly.This may prevent the device from being able to provide defibrillation therapy, if it were needed.There was no patient use associated with the reported event.
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