Alerta De Seguridad para LEGENDAIR Pulmonary Ventilator. Anvisa Record: 80136710174.

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.

According to the record holder, the internal batteries (in conjunction with the battery system controller) may cause the internal battery controller to trigger the safety mode of the equipment and, as a consequence, turn on a high priority alarm. In this case the alarm would be triggered unnecessarily, which can lead to an incorrect decision making on the part of the users. Anvisa's Technovigilance Unit is following up on this case. #### UPDATE (07/04/2011): The company sent a communication to UTVIG / ANVISA (Expediente: 585270 / 10-6) informing the finalization of corrective actions. According to the company, all equipment at risk in Brazil (36 units) were corrected (battery replacement). The company sent copies of the Service Orders corresponding to the correction services. Related documents: NOTIVISA 2010.04.000814, Files 054579 / 10-1 and 585270 / 10-6.