Events

Alerta De Seguridad para • Commercial name; LIFEPAK 1000 Defibrillator. • Technical Name: Defibrillator. • ANVISA Registry Number: 10339190300. • Classification of Risk: Class III - High Risk. • Affected models: 99425-000149; 99425-00148

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC COMERCIAL LTDA; Physio-Control, Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2059
  • Fecha
    2017-01-19
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    According to the company, immediately follow the Required Consumer Actions set forth below. If these steps are followed, your device may be kept in use. If the device unexpectedly shuts down during inspection or during patient care, immediately remove and reinstall the existing battery to restore power to the device. If the power is not restored, replace the battery with a spare battery and call Medtronic (0800-179944) immediately to arrange for service. Actions for the Device: 1. Remove and immediately reinstall the battery of your LIFEPAK 1000 defibrillator. Removing and reinstalling the battery will remove the oxidation from the contacts and restore the power to the device. 2. It is critically important that you implement a weekly battery removal and installation schedule for all LIFEPAK 1000 devices. Removing and reinstalling the battery each week will help ensure that your device is ready for use. It is also important to always have a spare battery charged. Attached to this we include a battery inspection checklist for your use. This weekly battery removal schedule must be run until the fix of the device has been completed. WARNING: As of 01/02/2016, the product has been imported by VR Medical under registration number 80102511545 - SEE ALERT 2060 If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events ( EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    The foreign manufacturer - physio-control - received 34 reports of incidents in which consumers attempted to use the lifepak 1000 defibrillator and the device shut down unexpectedly during the treatment of the patient. this unexpected shutdown is due to an intermittent connection between the battery and the device contacts. a defibrillator in this setting may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious injury or death. we are aware of 8 adverse events related to this problem. according to the company, this intermittent connection is the result of a wear and subsequent formation of oxidation between the battery and the electrical contacts of the device. it has been observed that this occurs in devices that are exposed to vibration and with the battery installed for prolonged periods without removal of the lifepak 1000 for inspection and new installation. the lifepak 1000 defibrillator operating instructions guide users to thoroughly inspect battery and battery contacts routinely as part of the maintenance and testing schedule. these events did not occur in brazil.
  • Acción
    Field Action Code FA724 triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA for Field Correction to update the care with the equipment. ATTENTION: For affected products in Brazil, the customer should contact the holder of the registration of the product in our country and not with the foreign manufacturer, as stated in the Letter to Customers.

Device

• Commercial name; LIFEPAK 1000 Defibrillator. • Technical Name: Defibrillator. • ANVISA Registry...

Manufacturer

MEDTRONIC COMERCIAL LTDA; Physio-Control, Inc.
  • Source
    ANVSANVISA