Alerta De Seguridad para POWERHEART AUTOMATIC EXTERNAL DEFIBRILLATOR. Models existing in Brazil that may be affected: 9300A, 9300C, 9300E and 9300P, produced between August 2003 and August 2009. ANVISA records: 10265410052 (Tecnimed Comercial Ltda) and 10312210014 (Medcorp Hospitalar Ltda). Affected serial numbers: check at www.cardiacscience.com/AED175.

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.

Cardiac Science Corporation has initiated a voluntary field action for POWERHEART automatic defibrillators due to a problem that affects the electronic components of some of these devices. According to information received by the Anvisa Technovigilance Unit (UTVIG / ANVISA), the problem may be related to the operation of resistors that equip the defibrillators. In order to correct the problem, Cardiac Science Corporation has already started the development of a software update for the affected equipment, which should be installed in the equipment that is in the field as of May 2010. The UTVIG / ANVISA has already initiated contact with the holders of product registration in Brazil and is following up on this case.