(udi) and pma/(510k) are unknown; no additional information was provided.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No lot number was provided; therefore, device history record review could not be completed.No product was returned for evaluation.One (1) picture was received.According to picture received, a broken breathing bag was shown.Root cause could not be determined.After a review of the different verifications that are performed during the manufacturing process to detect damaged components, the most probable root cause is that damage occurred after the product left the manufacturing facility.Actions (s) taken to mitigate the reported issue(s): as a preventive action production personnel was notified by quality intern as awareness of the defect reported by the customer.
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