A part of the spur ii was reported to be missing.This resulted in insufficient resuscitation of a patient.The patient died.No sample was returned for investigation.Per confirmation by the customer, the reported issue was that the outlet connector on the patient valve was missing due to a use error.Someone had removed expiratory/outlet connector at customer side in order to use it with another spur ii resuscitator.The reported product was manufactured and controlled in accordance with the working instructions.100% visual inspection and 100% function testing is performed on spur ii to make sure the product is performing as specified when delivered to the customer.It is stated in the instructions for use that a functionality precheck should always be performed before using the product on a patient.Had this been done, the user would have discovered that a piece was missing and other means of resuscitation could have been used in stead.
|