Events

Alerte De Sécurité sur Equipment for angiography ALLURA XPER FD10 (floor), FD10 (ceiling), FD20 (floor), FD20 (ceiling), FD10 OR Table; FD20 OR Table; FD10 / 10; FD20 / 20. Risk class: III, Record: 10216710153 and 10216710206.

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.; Philips Medical Systems Nederland B.V..

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
    1623
  • Date
    2015-07-02
  • 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 the record holder's information, there is a possibility of collision of the equipment with the patient or with the staff present in the room when the ceiling suspension of the monitors falls to their lowest position. There is also the possibility that the ceiling suspension of the monitors will collide with other equipment that is close to it. #### UPDATED ON 7/18/2017, the company sent a field action completion report confirming the replacement of the part , as provided.
  • Cause
    According to the record holder, a fault in the allura xper system monitor ceiling suspension (mcs) was found.
  • Action
    The company that owns the registry will make a correction in the equipment field. A containment action will be taken in which loops will be attached to the MCS to prevent them from falling. It is recommended that the user does not position or move the monitor ceiling suspension above the patient and do not allow the staff to be below or near the ceiling suspension of the monitor.

Device

Equipment for angiography ALLURA XPER FD10 (floor), FD10 (ceiling), FD20 (floor), FD20 (ceiling),...

Manufacturer

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