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.
데이터 추가 비고
원인
If the li-ion battery is accidently dropped the impact may cause the battery to vent. in addition to the risks contained in the warnings section of the operator/user instructions battery venting has the potential to create smoke a foul odor and sparks.
Model Catalog: 0998-00-0800-XX (Lot serial: to Nov 2016); Model Catalog: 0998-00-0800-XX (Lot serial: ALL Li-Ion batteries); Model Catalog: 0998-00-0800-XX (Lot serial: distributed from Dec 2011)
제품 설명
CARDIOSAVE HYBRID AND RESCUE INTRA-AORTIC BALLOON PUMP