Heartstart MRx Defibrillator, Philips brand, model: M3535A, M3536A, Registro ANVISA: 10216710136 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.

When monitoring through ECG electrodes, there is a potential for: • Loss of stimulation demand mode • Inability to perform synchronized cardioversion with blades • Interruption of ECG monitoring You can continue to use the MRx before installing the update of the hardware being aware that if this problem occurs, you may experience the following symptoms: • Loss of stimulation demand mode • Inability to perform synchronized cardioversion with blades • Interruption of ECG monitoring or INOP messages If these problems occur, consult the HeartStart MRx Instructions for Use for troubleshooting assistance. In addition, the following measures can be taken: • If pacing demand mode is not available, fixed pacing mode can be used. Change the pacing mode to "fixed" in the pacing mode menu. • If synchronized cardioversion with the blades is not available, synchronized cardioversion with blades can be used. Switch to blades • If monitoring of ECG electrodes is not available, ECG monitoring via blades / blades is available. Plug the blade or paddle cable and push the branch selector button until the ECG waves from the blades or blades are displayed. • Connect a separate ECG trunk cable, if available. Important Note: Defibrillation, fixed pacing mode, paddle / paddle ECG monitoring, and other monitoring functions are not affected by this problem.