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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Three issues were identified with these units. these include locking up of the display / control panel when the chamber is first turned on. this prevents initial operation of the chamber. the condition can be cleared by temporarily unplugging the chamber from the wall power source and disconnecting the battery back-up. this resets the control panel. once this is performed the chamber can continue to be used. the second is the chamber going into the safe state condition during treatment when the operator has touched or adjusted the controls. after completion of decompression in the safe state mode the treatment can be resumed. following the safe state initiation an inspection of the chamber does not indicate any anomaly that would result in the initiation of a safe state condition. the third issue involves the chamber automatically going into a safe state condition during treatment on its own without any operator action. following the safe state initiation an inspection of the chamber fails to indicate any anomaly that would result in the initiation of a safe state condition. no reports of injuries or death reported.