Alerta De Seguridad para Trade name: Defibrillator / Monitor. Technical name: DEFIBRILLATOR / MONITOR. ANVISA registration number: 80102511541. Risk class: III. Affected model: LIFEPAK 15. Serial numbers affected: 44574467; 44574771 and 44574821

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR MEDICAL 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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    User Testing The User Test is a functional test of the LIFEPAK 15 monitor / defibrillator. User Testing should be performed only for the purpose of testing, not while using the defibrillator for patient care. Run the User Test as a part of the Operator's Daily Checklist. Note: The defibrillator must be in Manual mode to run the User Test. To run the User Test outside of the Operator Checklist: 1. Press ON to turn on the LIFEPAK 15 monitor / defibrillator. 2. Press OPTIONS. The Options menu is displayed. 3. Select USER TEST. The defibrillator performs the following tasks: • Self-test to check the device: • Charges to 10 joules and discharges internally (this power can not be accessed in the therapy connector.) • Prints an approval / failure report. - If the LIFEPAK 15 monitor / defibrillator detects a fault during the User Test, the Service LED turns on and the printed report indicates that the test failed. Remove the use defibrillator and contact a qualified service technician. If you need to stop the User Test, turn the device off and then on again. The test is interrupted and the defibrillator operates normally. The approval / failure report does not print. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) 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 - Date of identification of the problem by the company: 03/02/2017 - Date of notification notice to Anvisa: 08/17/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    Physio-control has become aware of a potential problem in the device that may make it impossible for the lifepak device 15 to provide energy for defibrillation due to the possible failure of an internal (relay) component installed in the therapy printed circuit board assembly (pcba, the detection of the problem was based on a (01) complaint received outside brazil where an equipment failed the user's daily test (instructed by the service manual). the device displayed "abnormal energy delivery" and logged error code a51e. the relay defect can be identified during the device user test, as described in the chapter titled "equipment maintenance" in the lifepak 15 operating instructions (see the excerpt of the operating instructions on page 2 of this notice).
  • Acción
    Field Action Code AC007-17 triggered under the responsibility of the company VR MEDICAL LTDA. Company will test user for later field correction if necessary.