Events

Alerte De Sécurité sur Heartstart MRx Defibrillator, Philips brand, model: M3535A, M3536A, ANVISA Registration # 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
    1363
  • 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
    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.
  • Cause
    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
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA