D4: udi is (b)(4).H4: date of manufacture is unknown because the product was not returned to gehc.Investigation findings: gehc requested additional information from the customer however, limited clarification was provided.It was acknowledged that during the event, the gehc anesthesia machine provided multiple alarms to alert the user.The patients current condition is unknown.The plastic object was discarded by the customer but it was alleged that it came from the pedi-lite+ product/packaging.They declined to provide the actual pedi-lite+ involved in the event to gehc engineering for evaluation.Pictures of the affected pedi-lite+ showed an intact device with no indication that the plastic object came from the pedi-lite+ body.Pieces from the same lot as the affected pedi-lite+ were sent gehc engineering whereupon inspection, showed no defects in the product or packaging.In a review of historical data, no other complaints were identified related to this issue.Due diligence when assembling the patient circuit per the instructions for use should allow the issue to be identified prior to connecting the patient.The investigation concluded that based on the data and information available, the root cause was undetermined because the plastic object that was alleged to have caused the obstruction could not be confirmed to have come from the pedi-lite product/packaging.
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