(b)(4).Physio-control evaluated the customer's device and observed the reported issue.The device would not complete charging to the selected energy level and would display an "abnormal energy" message, when the charged energy is delivered.It was observed that the biphasic module had been physically damaged.After replacing the biphasic module and performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
|
A third-party service agent contacted physio-control to report that their customer's device had made a noise during a functional test and some smoke had appeared.During an initial evaluation, physio-control observed that the device would not complete charging to the selected energy level and would display an "abnormal energy" message, when the charged energy is delivered.In this state, the device would not be able to provide proper defibrillation therapy, if it were needed.There was no patient use associated with the reported event.
|