(b)(4).Physio-control evaluated the customer's device but was unable to duplicate the reported failure to complete the initial boot-up cycle in order to power on.Physio-control did, however, observe that the device was unable to detect that a test load was connected via a therapy cable.As a result, the device would not be able to defibrillate if it were necessary.Physio then replaced the system controller pcb assembly to resolve the observed issue and completed other, unrelated, repairs.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.Physio-control further evaluated the removed sc pcb assembly and confirmed that it had caused the observed issue.Physio found that the pcb does not allow for proper measurement of impedance.However, further component level cause could not be determined.The cause of the original reported issue (failure to complete the boot-up cycle) could not be determined.
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