Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda.; Philips Medical Systems.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1914
  • Date
    2016-04-26
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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 +.
  • Action
    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
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA