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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Terumo cardiovascular systems (terumo cvs) has received three reports of a terumo advanced perfusion system 1 displaying a pressure reading of '999.' terumo cvs has confirmed that in one of these cases the user was unable to clear the pressure alarm and restart the pump. note: the system displays '999' at pressures greater than +900mmhg. the reading can indicate a true high pressure or a malfunction of the pressure transducer or cable. the operator's manual for the terumo system 1 does not provide instruction on how to clear the '999' pressure reading.