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 become aware of an issue whereby the lifepak cr plus aed or lifepak expressaed may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. physio-control has determined that there are presently 25178 devices in the field of which approximately 9600 may have this faulty component. a defibrillator in this condition is not delivered and a patient is not resuscitated. all reports received from customers have been noted during initial set up and testing of the device.