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/datascope has identified an uncharacteristic increase in the number of screen display related issues reported on the intra-aortic balloon pumps (iabp). the display controller assembly with date code 08_05 was defective and is associated with this issue. we are recalling iabp's manufactured with the display controller assembly date code 08_05. this issue may cause the iabp to exhibit display distortion 'pixeling' and blanking. although the iabp continues to deliver therapy to the patient these issues cause the user to be unable to read the information that is being displayed.