Alerta De Seguridad para AUTOPULSE RESTORATION SYSTEM MODEL 100. Anvisa Registry n ° 10429990044.

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.

Complaints received by the product manufacturer associated with an "unexpected shutdown of Autopulse compressions" are commonly caused by users failing to properly perform the required preventive maintenance and daily check-in tasks. Proper use of the product requires daily rotation routine and monthly battery cycle tests (daily battery charging and rotation in combination with monthly battery cycling test). The manufacturer, in order to minimize the risk of such situations, established the need for daily verification by the user of the product of the operation of the batteries of these devices. This is not only a recommendation, since the user must perform the procedures in order to avoid risk of malfunction or non-operation of the equipment. Anvisa's Technovigilance Unit is monitoring the case and new information, as soon as it is available, will be updated in this alert.