Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Physio-control has received complaints that the lifepak 1000 defibrillator is unexpectedly powering off during device usage. this unexpected shut down is due to an intermittent connection between the battery and device contacts. a defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt which may expose patients to the risk of serious harm or death. this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. this has been observed to occur in devices that are exposed to vibration and have a battery installed for extended time without being removed from the lifepak 1000 for inspection and then reinstalled.