LIFEPAK® 1000 defibrillator 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.

Risk of failure to deliver a shock.This is due to unexpected shut down of the defibrillator caused by a battery with very low charge.Confusing instructions for use mean that batteries aren’t always replaced when they have a low or very low charge.See the Field Safety Notice (279Kb) for further details.