Device evaluation of the alleged malfunction required retrieval of the device from the patient; return to the contract manufacturer for decontamination, inspection and initial testing; followed by shipment to the manufacturer of record for failure investigation and root cause analysis.Returned therapy cable passed weight, safety, and eit.The returned monitor was tested and passed both isl (safety) and eit (performance) testing.The returned device passed all field return tests and inspections.The reported condition was not able to be replicated.There is no indication of a product malfunction.The reported service error code alert can be attributed to a system power-on self-test fault detected when a patient plugs and unplugs the therapy cable during system boot up.Will continue to monitor and trend service code issues for failure modes.
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