Events

Alerta De Seguridad para Name: HeartStart - ANVISA Registration Number: 10216710136 and 10216710271 - Technical Name: Defibrillator - Risk Class: III - High Risk - Model Affected: MRx and XL + - Affected Series Numbers: Affected Series in ANNEX

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.; Philips Medical Systems.

¿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
    1914
  • Fecha
    2016-04-26
  • 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
    Recommendations for Users and Patients: Before receiving a replacement sync cable, you can continue to use the affected sync cables as long as they are used only to connect the ECG output plug on the monitor / defibrillator to the (input) port of the ECG on a bed monitor. The issues described in this letter 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. 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.
  • 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
    The company is doing Field Correction - Replacement of the affected synchronization cables; Field Action Code: FCO86100165; 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. (Letter to the client in the ANNEX)

Device

Name: HeartStart - ANVISA Registration Number: 10216710136 and 10216710271 - Technical Name: Defi...

Manufacturer

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