Events

Safety Alert for Products affected by the Field Action: (i). Cardioversor Life 400 Plus Futura - Registration: 80058130010 - Class III; (ii). Cardioversor Vivo - Registry: 80058130015 - Class III. DISTRIBUTION MAPS (IN BRAZIL AND TO THE EXTERIOR) AND SERIES AFFECTED IN ANNEX.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by CMOS DRAKE DO NORDESTE LTDA.

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
    1833
  • Date
    2016-03-15
  • 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
    According to CMOS DRAKE, "The watchdog circuit already existing on the Cardioversor has the sole and exclusive purpose of resetting the equipment in case the equipment is locked for external reasons. It is not mandatory, as it does not influence stability, safety, does not affect performance and does not change the functional characteristics of the equipment. The mentioned technical intervention will allow the Watchdog circuit to work within a range closer to the limits calculated for the reset, guaranteeing better performance of the circuit in question. "##### UPDATE: On 02/22/2016 Certification of Good Manufacturing Practices of CMOS Drake of Nordeste Eireli - CNPJ: 03.620.716 / 0001-80, published by Resolution RE No. 4,482, of 11/14/2014, published in the DOU nº 222, of 11/17/2014 ( Section I, pages 43 and 44, and in Supplement to Section I, page 168), considering the non-compliance with the Good Manufacturing Practices requirements set forth in current legislation for the Health Products area. / 04/2016 was rejected the request Certification of Good Practices of Manufacture of Health Products of the Company DC Heart Defibrillators and Medical Systems Ltda. - CNPJ: 13.676.954 / 0001-60, through RESOLUTION - RE N ° 1,043, OF 20 OF APRIL 2016, published in DOU DE 04/25/201 6 ## UPDATE ON 07/4/2016: CANCELLATION BY THE CERTIFICATION ORGANIZATION OF THE CERTIFICATES FOR THE REFERRED PRODUCTS, AS FOLLOWS "II - Cancellation by other types of non-conformities not related to tests. Evidences of non-conformities and deviations from process encountered in the QMS during the maintenance process. " ## UPDATE: On 08/18/2016 Intertek issued the Certificates Numbers MED 0521 / C 0689.16 and MED 0521 / C 0688.16, for the Vivo Cardioversor products - Registration: 80058130015 and Cardioversor Life 400 Futura - Registration: 80058130008, respectively.
  • Reason
    Replacing the d59 diode that is within a working range closer to the calculated limits for the reset in the event of an external fault causing the machine to be locked.
  • Action
    The field action involving the Life 400 Plus Futura and Cardioversor Vivo Cardioversors is aimed at replacing a diode located at position D59 of the electronic circuit board CBI300.03 in order to improve the efficiency of the watchdog circuit (responsible for restarting the machine if there is any blocking by external events) a) Classification of risk CLASS III - Situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences; b) Classification of the field action - Correction in the field for correction of parts and pieces; c) Field action code - 001/2016; d) recommendations to users and patients - The watchdog circuit is not designed to provide user and patient safety, but to reset the device when possible external events cause it to crash (which rarely happens). The equipment can be used normally without any limitation as it does not influence the stability of the product and does not affect its performance. LETTER TO THE CUSTOMERS IN ANNEX. Code 001/2016

Device

Products affected by the Field Action: (i). Cardioversor Life 400 Plus Futura - Registration: 800...

Manufacturer

CMOS DRAKE DO NORDESTE LTDA
  • Source
    ANVSANVISA