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Using Failure Modes, Mechanisms, and Effects Analysis in Medical Device Adverse Event Investigations
In the United States, when medical devices are associated with adverse events that result in death or serious injury, or have malfunctions that could lead to death/serious injury, these events must be reported to the Food and Drug Administration’s Center for Devices and Radiologic Health by device manufacturers and user facilities. However, the defects in the medical device evaluation process (...
An integrated manufacturing process simulation framework has been developed to predict the trimmed edge tensile stretchability of AA6111-T4 sheets by incorporating the burr geometry, damage, and plastic strain from trimming simulations into subsequent tensile stretchability simulations. The influence of the trimming die clearances on the predicted tensile stretching ductility (stretchability) i...
Status of This Memo This memo provides information for the Internet community. It does not specify an Internet standard. Distribution of this memo is unlimited. Abstract This note describes some theoretically-possible failure modes for TCP connections and discusses possible remedies. In particular, one very simple fix is identified.
it is not possible to understand developments of a country’s culture and civilization without knowing his believes and myths. whether it is north or south, east or west, planes or mountains, sahara or deserts, here in iran every corner includes valuable and precious treasures which are known all over the world, and cultural – historical objects which are found here adorn all well known museums...
MEMS components by their very nature have different and unique failure mechanisms than their macroscopic counterparts. This paper discusses failure mechanisms observed in various MEMS components and technologies. MEMS devices fabricated using bulk and surface micromachining process technologies are emphasized.
Long life has been billed as a key advantage of LEDs, but understanding and communicating how LED products fail and how long they last can be challenging. While LED-based products hold the potential to achieve lifetimes that meet or exceed their traditional counterparts, manufacturer claims can be misconstrued by users who do not fully understand LED product failure mechanisms or the difference...
A new novel test method, associated analysis, and experimental procedures are developed to investigate the toughness of the facesheet-to-core interface of a sandwich material at cryogenic temperatures. The test method is designed to simulate the failure mode associated with facesheet debonding from high levels of gas pressure in the sandwich core. The effects of specimen orientation are conside...
The structure signature of a system made up of n components having continuous and i.i.d. lifetimes was defined in the eighties by Samaniego as the n-tuple whose k-th coordinate is the probability that the k-th component failure causes the system to fail. More recently, a bivariate version of this concept was considered as follows. The joint structure signature of a pair of systems built on a co...
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