The affected breathing circuit was available for investigation.The reported problem of a detached y-piece could be confirmed.Further analyses have shown that the y-piece did not conform to specification due to wear and tear of the respective tool.A random sample from stock was inspected.It was found, that out of (b)(4) samples did not withstand the specified load test.Since it could not be determined when the wear and tear began to impact the strength of the adhesive joint, it was assumed that all circuits in the field may be affected.A capa was opened to initiate and document further measures.Dräger finally decided that all customers of dräger neo disposable breathing systems shipped during the last 3 years have already been/will be informed with a field safety notice which provides a description of the identified risk and advice how carefully check the devices prior to use.In the meantime the tool has been re-worked, so that new y-pieces are manufactured according to specification.In addition the gluing process has also been improved with more strict requirements regarding location and amount of the applied adhesive.
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