Events

Safety Alert for Heartstart MRx Defibrillator, Philips brand, model: M3535A, M3536A, ANVISA Registration # 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
    1363
  • 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
    The MRx may stop charging, defibrillating or stimulating, causing a delay in therapy. According to the manufacturer, you can continue to use the MRx before receiving the hardware upgrade, as long as you notice that if the MRx displays a red X on the RFU (ready-to-use) indicator during automated testing, a fault has been detected and can prevent the delivery of a shock or stimulation due to this problem. If this is found you should turn the Therapy button to Monitor. An INOP message describing the fault is displayed. If necessary, run an operational check for more information. If the condition persists, remove the device and call for service. Use a backup defibrillator in case an affected MRx does not deliver therapy.
  • Reason
    An internal component in the heartstart mrx therapy board may malfunction, potentially affecting the ability to deliver therapy. mrx, specifically, may be unable to carry and deliver the shock. in addition, when used for external stimulation, malfunction may result in loss of capture during stimulation. the mrx may display a red x on the rfu (ready for use) indicator during automated testing informing the user that a fault has been detected and that it can prevent the delivery of a shock and stimulation.
  • Action
    Field correction and software update

Device

Heartstart MRx Defibrillator, Philips brand, model: M3535A, M3536A, ANVISA Registration # 1021671...

Manufacturer

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