Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Tecnimed/Paramedics Eletromedicina Comercial Ltda e Medcorp Hospitalar Ltda; Cardiac Science Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1002
  • Date
    2010-01-15
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Equipment may not release therapeutic electrical discharge, compromising the patient's resuscitation procedure.
  • Action
    The manufacturer (Cardiac Science Corporation) has initiated product corrective action (upgrade software), which is expected to be available through May 2010. It is recommended that users replace defibrillators at use by backup equipment, if possible, until the update is made by the registry holder. If replacement of the affected equipment is not possible, it should be used normally and the maintenance provided in the manuals should be performed routinely. It is also essential that users periodically check the operating status indicator of each device on the front of the device.

Device

POWERHEART AUTOMATIC EXTERNAL DEFIBRILLATOR. Models existing in Brazil that may be affected: 9300...

Manufacturer

Tecnimed/Paramedics Eletromedicina Comercial Ltda e Medcorp Hospitalar Ltda; Cardiac Science Corp...
  • Source
    ANVSANVISA