The affected resuscitator was not received for investigation, neither was a picture provided.Contacted customer several times to obtain more information about the incident, customer is not responding.Product was manufactured and tested according to working procedure.High/low pressure test, inspiratory resistance test, valve function test, reservoir bag test and spontaneous breathing test were performed according to work instructions to ensure the product can meet the product specifications.Due to limited information, it is difficult to verify the reported failure and the root cause of the reported failure cannot be identified.Spur ii resuscitator is designed for use by cpr-trained personnel only, and information for safety provided in accompanying document (ifu) inform that a functional test must always be performed after unpacking, cleaning, assembly and prior to use.No causal relationship has been established between reported failure and patient outcome.Device was not returned for evaluation.
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