Events

Alerte De Sécurité sur HeartStart MRx Defibrillator - Models M3535A, M3536A - Registration 10216710136 - Serial Numbers - See Annex (http://migre.me/9GSbs).

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
    1148
  • Date
    2012-06-29
  • 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
    When HeartStart MRx Defibrillator Monitors are used in external transport and in SEM environments, the electrical / mechanical connection (pin plugs and / or port pins) between the patient electrode / blade cable (including the CPR therapy cable and the cable of the external electrodes) and the MRx patient connection port may have higher than expected voltage levels, accelerating wear. Without periodic routine inspections and user-initiated preventive actions, wear of the connection may prevent the device from identifying the connection to a patient electrode / blade cable. Such wear may also cause the MRx to inappropriately identify the patient cable from the external or internal paddles and electrodes.
  • Cause
    The patient cable of the electrodes / paddles and the patient connection port may pose risks to patients and / or health care professionals.
  • Action
    Carefully read the Appendix - HeartStart MRx Instructions for Use. Immediately perform continuous inspection of the connections of all your MRx devices to detect wear at higher than expected voltage levels. The Annex - HeartStart MRx Instructions for Use describes how a wearer can identify wear. If wear is detected, immediately remove the affected devices and contact Philips to arrange maintenance. NOTICE: The life of your patient / external electrode cables is up to three years. To maintain reliable performance and reduce the possibility of failure during patient use, replace such parts every three years from the time they were put into service or if they do not meet the criteria set out in the Annex - use. (http://migre.me/9GSkE)

Device

HeartStart MRx Defibrillator - Models M3535A, M3536A - Registration 10216710136 - Serial Numbers ...

Manufacturer

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