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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Customer complaints associated with the prevalon airtap system booster pump (model 7450) have identified poor reliability in the field. there are two failure modes identified: lack of power due to a hardware failure internal to the booster pump and damage to the hose.