Alerta De Seguridad para Trade name: Ventilator /// Anvisa Registration n ° 80047300528 /// Technical name: Fan Pressure and Volume /// Risk class: III (High Risk) ///; Affected model (s): Astral 100 / Astral 150 /// Serial number (s) affected: See Annex.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA; ResMed Ltd..

¿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
    1994
  • Fecha
    2016-09-06
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    ATTENTION: The precautions described in the Astral labeling and in the safety warning issued by the company must be obeyed. SERVICE REQUIREMENTS: Astral batteries should be inspected regularly according to the User Manual. The ResMed or ResMed Authorized Service Center will also check the internal battery performance performance and software updates. Customers with equipment approaching the two-year maintenance cycle should contact an Authorized Service Center to arrange maintenance service.
  • Causa
    When astral fans are used with the internal battery as their only electrical source, it is important to note that internal battery failure can lead to interruption of treatment without "battery low" or "critically poor battery" alarms even firing battery is charged. in such cases, ventilator-dependent patients (patients unable to maintain adequate ventilation without assistance and deteriorating conditions) may be at risk if no urgent action is taken to restore energy or to initiate an alternative form of ventilation. resmed received a small number of reports (<0.1% of handsets sold globally) of a performance problem associated with the astral 100 and 150's internal batteries. although these events are extremely rare, it is important that you follow the important ones you follow the precautions described in the astral labeling and this fsn.
  • Acción
    Field Action code 9 triggered under the responsibility of the company MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA. Company issued Safety Alert with precautions to be taken by users, caregivers and health care workers Precautions to be taken by users / caregivers in the home or health / hospital environment 1.Connect the ventilator to electrical power via alternating current whenever possible. In the event of a battery failure, connect the device to the AC source immediately to resume ventilation. 2. If possible, use an external power source (external Astral battery or RPSII battery) for ventilation dependent patients. 3. If possible, use an external power source (Astral external battery or RPSII battery) in mobile situations, including when AC power is unavailable or is interrupted. Do not rely solely on the internal battery for mobile use. 4. Ensure that the external battery source is sufficiently charged before using the equipment in mobile situations. 5. When treating ventilator-dependent patients, always have alternative ventilation equipment available, such as a back-up ventilator, manual resuscitator, or similar device. 6. Ventilation dependent patients should be continuously monitored by qualified personnel or appropriately trained caregivers. Such persons and caregivers should be able to take corrective action in the event of a malfunction of the ventilator alarm. 7. Follow Astral's maintenance service plan every two years. At this point, the internal battery will be replaced. 8.Equipments with batteries approaching two years of use and with frequent battery depletion should be monitored for battery performance verification in accordance with the operating instructions, including a periodic check that the battery has adequate charge capacity. Batteries that have reduced performance performance should be replaced immediately. 9. Return the equipment to a Service Center if it presents any reports of battery problems or significant degradation of battery performance.