Events

Alerte De Sécurité sur HEARTSTART MRX DEFIBRILLATOR - Models M3535A and M3536A. Anvisa Registry: 10216710136.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Philips Medical Systems Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1022
  • Date
    2010-06-02
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    According to information presented by Philips Medical Systems Ltd., after two years of continuous use mechanical wear caused by vibration and frequent disconnections may cause an intermittent electrical connection between the battery and the equipment. The power outage during the use of the equipment may cause it to restart with interruption of therapy (monitoring of the electrocardiogram / electric shock for defibrillation of the heart muscle). #### Update (20/06/2012): Philips Medical Systems Ltda informed the UTVIG about the completion of the field action. According to the company, the addendums to the instructions for use were sent to affected customers in Brazil.
  • Cause
    Blinking electrical connection between the battery and the equipment, which may cause the defibrillator to fail.
  • Action
    The company sent an informative letter to customers, with an addendum to the instructions for use of the equipment (Notice of Application of the Instructions for Use of the Lithium Ion Battery M3538A). It is recommended that all affected batteries be replaced after two years of continuous service, or when the battery capacity calibration fails, whichever comes first. The details of the instructions should be verified in the Letter to Customers (available at http://portal.anvisa.gov.br/wps/wcm/connect/f13aa60042b4e27f8b89cbb134f70e0f/Carta+a++Clients.pdf?MOD=AJPERES) and in the Addendum to Instruction Manual (available at http://portal.anvisa.gov.br/wps/wcm/connect/3b74638042b4e3228b92cbb134f70e0f/Adding+to+Manual+of+Instructions+.pdf?MOD=AJPERES) .

Device

HEARTSTART MRX DEFIBRILLATOR - Models M3535A and M3536A. Anvisa Registry: 10216710136.

Manufacturer

Philips Medical Systems Ltda.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA