HeartStart MRx Monitor/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.

The Philips HeartStart MRx Monitor/Defibrillator may fail to deliver defibrillation therapy in either “Manual Defib”, “AED” or “Sync Cardioversion” mode.If this occurs, the MRx will simultaneously display the following:Flat line ECG.
“Device error. Service required” message.
“Shock Equip Malfunction” INOP.
Red “X” in the RFU indicator.If the problem occurs it can impact either cardioversion or defibrillation therapy within the specified modes.  Pacing is not affected.