Events

Safety Alert for Heartstart MRx Defibrillator, Model M3535A, M3536A - ANVISA Registry # 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
    1361
  • 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
    You can continue to use the MRx prior to inspection and installation of the upgrade hardware by your Philips Authorized Service Provider once you receive the notification: • Ensure that you are performing continuous inspections of the treatment connection on all MRx devices to detect the wear. The HeartStart MRx Instructions for Use, 453564396411 Issue 1, 453564307761 Issue 2, or 453564174011, a "Maintenance and Inspection of Treatment Connection When Using in Transportation" circulation, Addendum, Edition 6, describe how users can identify wear . • If wear is detected, immediately remove affected devices from use and contact Philips to program the service. After receiving the inspection and updating of the hardware (if applicable) from Philips, continue to perform continuous inspection of the treatment connection in accordance with the HeartStart MRx Instructions for Use to detect any wear in the future. WARNING: The life of the treatment cables / outer blades is up to 3 years. To maintain performance reliably and to reduce the possibility of failure during patient use, replace them every three years from the time they are used or if they fail to meet the criteria for inspection of the Instructions for Use. there is a potential that one or more of the following items may occur. • Delay in treatment • Incorrect energy distribution • Spontaneous / unintentional treatment energy discharge • Shock healthcare professional when administering treatment • Interruption of stimulation with loss of catch and inability to recapture.
  • Reason
    When used in hospital or pre-hospital transport (emergency medical support), the connection between the pad therapy cable (including the cardiopulmonary resuscitation pad therapy cable, external pad cable and internal pad adapter cables / adapters ) and the inlet of the mrx connection may present high levels of stress, causing accelerated wear. connection wear can prevent the device from detecting that the blade handling cable is connected. this wear may also cause the mrx to inappropriately identify the handling handle for blades, outer blades, or inner blades. the wear of the treatment cable of the birds and the treatment connection inlet may present a risk to patients and / or health professionals.
  • Action
    Software Update, parts / parts correction

Device

Heartstart MRx Defibrillator, Model M3535A, M3536A - ANVISA Registry # 10216710136

Manufacturer

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