The sample for the leaking manometer was returned to our manufacturing facility for investigation on may 07, 2021.The sample was immediately evaluated by the qa engineer.The following functional tests were completed on the returned sample: high/low pressure test.Volume test.02 concentration test recoil time test.Each of the above tests that we performed identified no failures with the returned sample.The results of all tests were within the product specifications.As described in the ifu, it is important to inspect the resuscitator and perform a brief functional test prior to use and to not use the product if a test for functionality fails.This mdr is resubmitted again as it was identified that original submission had not been successfully loaded into the fda database due to wrong file format.The initial mdr of this incident was submitted to the fda within the original reporting deadline.This submission represents a reload of data to ensure correct upload to the fda database.
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