Events

Alerte De Sécurité sur Angiography equipment, Risk class: III, models described below. Model: ALLURA XPER FD10 (floor), ALLURA XPER FD10 (ceiling), ALLURA XPER FD20 (floor), ALLURA XPER FD20 (ceiling), Registration: 10216710153 ////. Model: INTEGRISH5000 F, Record: 10216710034 ////. Model: Integris Allura 12/15, Integris Allura 12 / 15F, Integris Allura 9C, Integris Allura 9F; Record: 10216710155 ////. Model: ALLURA XPER FD10 / 10; ALLURA XPER FD20 / 10; ALLURA XPER FD20 / 20; ALLURA XPER FD10 / 10 OR Table; ALLURA XPER FD20 / 10 OR Table; ALLURA XPER FD20 / 20 OR Table; Record: 10216710206 .. Serial number: 176; 553; 759; 1751; 001H021796; 001H021878; S4F010159A; S4F200174A; S4F200270A

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
    1514
  • Date
    2015-02-05
  • 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, the risk is linked there is a possibility of collision of the equipment with the patient or with the staff present in the room. When suspended from the ceiling of the monitors, it may fall to its lowest position. There is also the possibility that the ceiling suspension of the monitors collide with other equipment that is close to it.
  • Cause
    According to the record holder, the ceiling suspending system of the equipment monitors may plummet to its lowest position which, after investigation pointed out that the cause of the failure was a montage suspended ceiling trigger assembly error.
  • Action
    The registrant has established the following guidelines for customers until the containment action is implemented: - Do not position or move the ceiling suspension of the monitors on the patient - Do not allow team members to be under or near the suspension monitors.- Avoid any unnecessary movement of the monitors suspended ceiling. " (SEE ATTACHED)

Device

Angiography equipment, Risk class: III, models described below. Model: ALLURA XPER FD10 (floor), ...

Manufacturer

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