The product was returned for investigation and the failure mode was not confirmed.Alleged failure: equipment used when patient "coded".Calling in just in case.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause as the unit passed the specific, functional tests for this product as per (b)(6).Therefore, this unit is deemed as no problem found.(b)(4).The reported failure mode will be monitored for future reoccurrence.
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