Alerta De Seguridad para Fan Model DX-3012. Series under risk: 140 units, disclosed by the company its risk statement (see annex). Anvisa Registry n ° 10293490037.

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.

During normal operation, the ventilator may suspend ventilation without any interaction or during the calibration process of the equipment. This process takes an average of 8 seconds, during which time there will be no ventilation for the patient. After the fault occurs, an emergency mode with high priority alarm is activated. Emergency ventilation uses a PCV mode with parameters set to be supported by different operating categories. To date, there are no reports of adverse events related to this problem according to Dixtal. The period of discontinuation of ventilation can cause serious consequences depending on the patient's clinical condition until emergency ventilation with a high priority alarm is activated. The repercussions vary from only a small respiratory discomfort almost imperceptible to the patient, to severe hemodynamic repercussions requiring medical intervention. Emergency ventilation is activated in PCV mode, which is safe, including the neonatal population, but may not be ideal for the patient at that time and therefore requires some adjustments by the medical staff.