Events

Safety Alert for EXTERNAL AUTOMATIC / SEMI-AUTOMATIC DEFIBRILLATOR Registration number ANVISA: 80117580147 Hazard class: III Affected model: CARDIOLIFE AED 2100K Serial numbers affected: Serial numbers: 10462, 10463, 10464, 10,461, 10466, 10467, 10468, 10469, 10470, 10471, 11588, 11589, 11590, 11591, 11592, 11593, 11594, 11596, 11597, 11599, 11600, 11601, 11602, 11603, and 11604.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by EMERGO BRAZIL IMPORT IMPORTAÇÃO E DISTRIBUIÇÃO DE PRODUTOS MÉDICOS HOSPITALARES LTDA; NIHON KOHDEN TOMIOKA 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
    2160
  • Date
    2016-11-16
  • 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
    As described in the operator's manual (Page 29), the user must perform daily inspection and among the items to be checked, it is indicated to check if the status indicator is green (ready to use).
  • Reason
    In rare cases, during the self-test (daily self-test of disposable electrodes, battery and internal electronic circuit test), a malfunction of the circuit may prevent the power off after the test and this causes the battery to drain .
  • Action
    Field Action Code RAM-14.2016 triggered under the responsibility of the company EMERGO BRAZIL IMPORT IMPORTATION AND DISTRIBUTION OF MEDICAL PRODUCTS HOSPITALARES LTDA. Company will make correction in Field.

Device

EXTERNAL AUTOMATIC / SEMI-AUTOMATIC DEFIBRILLATOR Registration number ANVISA: 80117580147 Hazard ...

Manufacturer

EMERGO BRAZIL IMPORT IMPORTAÇÃO E DISTRIBUIÇÃO DE PRODUTOS MÉDICOS HOSPITALARES LTDA; NIHON KOHDE...
  • Source
    ANVSANVISA