(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio determined that the cause of the reported issue was due to a solder defect on post 1 of integrated circuit, designator u1, on the analog pcb assembly.The customer received a replacement device.
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The customer contacted physio-control to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that the device delivered a monophasic shock at a reduced energy level.As a result, the wrong defibrillation therapy may be delivered to a patient, if it was needed.
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