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 cardiopulmonary recently detected a leak in the water circuit of an hcu 40 during the final quality inspection. the investigation revealed that the leakage was caused by a damaged sealant in the water circuit. the damage occurred during device assembly and it cannot be ruled out with absolute certainty that hcu 40s in the field equipped with the same type of sealant could exhibit this failure too. the hcu 40 with the serial number 90440265 could potentially exhibit a leak in the water circuit. in case of water leakage a short circuit of an electrical component and device shut down are the potential consequences.