Events

Alerte De Sécurité sur Heartstart MRx Defibrillator, Philips brand, model: M3535A, M3536A, Registro ANVISA: 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
    1362
  • 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
    When monitoring through ECG electrodes, there is a potential for: • Loss of stimulation demand mode • Inability to perform synchronized cardioversion with blades • Interruption of ECG monitoring You can continue to use the MRx before installing the update of the hardware being aware that if this problem occurs, you may experience the following symptoms: • Loss of stimulation demand mode • Inability to perform synchronized cardioversion with blades • Interruption of ECG monitoring or INOP messages If these problems occur, consult the HeartStart MRx Instructions for Use for troubleshooting assistance. In addition, the following measures can be taken: • If pacing demand mode is not available, fixed pacing mode can be used. Change the pacing mode to "fixed" in the pacing mode menu. • If synchronized cardioversion with the blades is not available, synchronized cardioversion with blades can be used. Switch to blades • If monitoring of ECG electrodes is not available, ECG monitoring via blades / blades is available. Plug the blade or paddle cable and push the branch selector button until the ECG waves from the blades or blades are displayed. • Connect a separate ECG trunk cable, if available. Important Note: Defibrillation, fixed pacing mode, paddle / paddle ECG monitoring, and other monitoring functions are not affected by this problem.
  • Cause
    The connection of the ecg trunk cable and the locking of the mrx connector may be subject to accelerated wear, which may result in an uninterrupted ecg signal. interruption of the ecg signal may cause: • loss of stimulation demand mode • inability to perform synchronized cardioversion with the paddles • interruption of monitoring of ecg leads, which may delay appropriate treatment defibrillation, fixed pacing mode , paddle / paddle ecg monitoring, and other monitoring functions are not affected by this problem.
  • Action
    field correction and software update

Device

Heartstart MRx Defibrillator, Philips brand, model: M3535A, M3536A, Registro ANVISA: 10216710136

Manufacturer

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