Events

Alerta De Seguridad para Trade name: HeartStart; ANVISA registration numbers: 10216710136 and 10216710271; Risk class: III; Affected models: MRx and XL +; Affected series / lots: US00119303; US00119304; US00121905; US00121913; US00122596; US00122597; US00122710; US00122711; US00122712; US00122779; US00122780; US00122781; US00122782; US00122783; US00607333; US00607334; US00607335; US00607336; US00607337; US00607338; US00607339 and US00607340.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda..

¿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
    1860
  • Fecha
    2016-04-01
  • 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
    Philips will replace all affected sync cables with a new cable for free. A Philips Healthcare representative will contact customers with the affected devices to arrange replacement. If you find it difficult to follow the instructions contained in this release, please contact our Philips Solution Center at 0800-701-7789. Service from Monday to Saturday from 07h to 19h. #### UPDATED ON 7/18/2017, the company submitted completion report of the field action proving the accomplishment of exchange, as planned.
  • Causa
    When a philips monitor / defibrillator is receiving an ecg signal from an auxiliary bed monitor via sync cable, if the monitor / defibrillator is subject to interference from efts while connected to ac power, the following may occur: • in heartstart mrx and heartstart xl, eft noise can be misinterpreted as an r-wave. • in the heartstart xl +, eft noise can deactivate ecg monitoring and possibly stop the stimulus in demand mode *. * note: it is contrary to the xl + instructions for use (ifu) to perform the stimulus in demand mode while using the sync cable to deliver the ecg signal from a bed monitor. the xl + ifu includes the following warning: when stimulating in demand mode, the patient's ecg cable must be connected directly to the heartstart xl +. "if you follow this warning, this problem can not occur on xl +.
  • Acción
    Field Action Code: FCO86100165. Field Correction by Replacing the Affected Sync Cables ///// Recommendations to Users and Patients: Before receiving a replacement sync cable, you can continue to use the affected sync cables provided they are used only to connect the plug ECG output on the monitor / defibrillator to the (input) port of the ECG on a bed monitor. The problems described do not impact this application of the sync cable. The affected sync cables should not be used to connect the ECG output plug of a bed monitor to the ECG (input) port on the monitor / defibrillator.

Device

Trade name: HeartStart; ANVISA registration numbers: 10216710136 and 10216710271; Risk class: III...

Manufacturer

Philips Medical Systems Ltda.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA