Events

Alerte De Sécurité sur Heartstart MRx Defibrillator, Model M3535A, 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.

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
    1361
  • Date
    2014-02-14
  • 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
    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.
  • Cause
    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
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA