Company: Boston Scientific Corp.Product: Investigational medical device Date: 8/22/03 For example, the …and the …do not describe whether the monitor should verify all case histories and related documentation or only select a representative sample during the visit. If a sample is to be selected, the procedures do not state the size and composition of this...Read More

An article in the August 22, 2003, Los Angeles Times by Charles Ornstein and Tracy Weber, Times Staff Writers, describes an incident where “two patients die after alarms fail”. Read article:  LATimesarticle822Read More