Philips Healthcare Applies Decision Analysis, a Systems Engineering Tool, to Mitigate Risk

摘要

Philips Healthcare took an unconventional approach to gain compelling insights into postmarket risk associated with an automated external defibrillator (AED), a device that treats sudden cardiac arrest by delivering a shock to the chest to restore heartbeat. A component of the device had a low failure rate, but a failure could be deadly. "An AED can sit dormant for many years, but when it's needed, it must work," said Greg Lancaster, senior reliability engineer at Philips Healthcare. The risk was discovered during periodic diagnostic tests of the devices by a fraction of customers. Sometimes, however, the diagnostic tests did not detect the problem.