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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Maquet/getinge has received a complaint involving a cs300 iabp that did not pump due to an electrical test failure code #58 (power up vent tests fail) maintenance code #3 and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy. an electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve. the lack of power prevents the coil from moving the plunger causing the valve not to open. this is recognized by the system as an electrical test failure code #58 upon powering on the iab. units distributed after december 11 2013 are not affected by the field correction.