Alerta De Seguridad para Heartstart MRx Defibrillator, Philips brand - Models M3535A, M3536A

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.

If the problem occurs, there may be a delay or interruption in defibrillation or cardioversion. The condition can be avoided by operating the device on an external AC or DC source. When using only the battery as a power source, observe the instructions for use to minimize or eliminate potential interference from other radio frequency sources. See section "Safety Considerations", "Immunity Emissions" in the MRx user manual for proper use of equipment in relation to electromagnetic emissions. If your equipment shuts off and the lights are off or weak, do the following: 1. Remove any potential RF source interference from the environment. 2. Replace the battery with a fully charged battery that has all 5 battery indicator lights on, or connect to an external power source.