Catalog number is unknown.Udi information is unknown.Operator of device is unknown.No information has been provided to date.Manufacturing site address is unknown.Remarket (510k) number is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.The sample was received in used condition without its original packaging.Visual inspection confirmed the breathing bag has a tear.Unable to determine the root cause of the reported issue.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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