Heartstart MRx Defibrillator, Philips brand, model: M3535A, M3536A, ANVISA Registration # 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.

The MRx may stop charging, defibrillating or stimulating, causing a delay in therapy. According to the manufacturer, you can continue to use the MRx before receiving the hardware upgrade, as long as you notice that if the MRx displays a red X on the RFU (ready-to-use) indicator during automated testing, a fault has been detected and can prevent the delivery of a shock or stimulation due to this problem. If this is found you should turn the Therapy button to Monitor. An INOP message describing the fault is displayed. If necessary, run an operational check for more information. If the condition persists, remove the device and call for service. Use a backup defibrillator in case an affected MRx does not deliver therapy.