Events

Safety Alert for Heartstart MRx Defibrillator, Philips brand, model: M3535A, M3536A, Registro ANVISA: 10216710136

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by 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
    1362
  • Date
    2014-02-14
  • 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
    When monitoring through ECG electrodes, there is a potential for: • Loss of stimulation demand mode • Inability to perform synchronized cardioversion with blades • Interruption of ECG monitoring You can continue to use the MRx before installing the update of the hardware being aware that if this problem occurs, you may experience the following symptoms: • Loss of stimulation demand mode • Inability to perform synchronized cardioversion with blades • Interruption of ECG monitoring or INOP messages If these problems occur, consult the HeartStart MRx Instructions for Use for troubleshooting assistance. In addition, the following measures can be taken: • If pacing demand mode is not available, fixed pacing mode can be used. Change the pacing mode to "fixed" in the pacing mode menu. • If synchronized cardioversion with the blades is not available, synchronized cardioversion with blades can be used. Switch to blades • If monitoring of ECG electrodes is not available, ECG monitoring via blades / blades is available. Plug the blade or paddle cable and push the branch selector button until the ECG waves from the blades or blades are displayed. • Connect a separate ECG trunk cable, if available. Important Note: Defibrillation, fixed pacing mode, paddle / paddle ECG monitoring, and other monitoring functions are not affected by this problem.
  • Reason
    The connection of the ecg trunk cable and the locking of the mrx connector may be subject to accelerated wear, which may result in an uninterrupted ecg signal. interruption of the ecg signal may cause: • loss of stimulation demand mode • inability to perform synchronized cardioversion with the paddles • interruption of monitoring of ecg leads, which may delay appropriate treatment defibrillation, fixed pacing mode , paddle / paddle ecg monitoring, and other monitoring functions are not affected by this problem.
  • Action
    field correction and software update

Device

Heartstart MRx Defibrillator, Philips brand, model: M3535A, M3536A, Registro ANVISA: 10216710136

Manufacturer

Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA