Edwards Lifesciences, LLC – FDA 483, Jun 14, 2019
Edwards Lifesciences, LLC in Irvine, CA, received a Form 483 with three observations related to its quality system for medical devices. The inspection revealed deficiencies in corrective and preventive action procedures, process controls for software problems, and complaint handling processes. These issues are serious as they relate to patient safety, specifically concerning the EV1000 Clinical Platform hemodynamic monitoring system experiencing fires due to liquid ingress and unaddressed software defects.
ID · 9ead4aac-9ba7-42ec-8836-36dde7f840fa
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.