Events

Alerte De Sécurité sur Angiography Equipment Allura Xper. Model (s): FD10 (floor); FD10 (ceiling); FD20 (ground); FD20 (ceiling); FD10 OR Table; FD20 OR Table; FD10 / 10; FD20 / 20; FD20 / 10; FD10 / 10 OR Table; FD20 / 20 OR Table; FD20 / 10 OR Table. Anvisa Registry n ° 10216710153.

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
    1744
  • Date
    2015-11-18
  • 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 company, the severity was classified as "results in less than moderate damage or does not result in damage" and the probability of occurrence was classified as a "considerable chance of occurrence". The audible signal is one of the tools available to help prevent unnecessary radiation to the patient. No injury attributed to the problem was reported. #### UPDATED ON 7/18/2017, the company submitted completion report of the field action verifying the accomplishment of correction, as expected.
  • Cause
    Philips healthcare has discovered, through customer complaints and internal testing, an intermittent electronic defect of the product. in certain circumstances, a software error may result in a situation where the five-minute audible audible signal does not sound, as required by standards 203c (10cfr1020.32 (h) (2) (ii) and iec 60601-2054, clause 203.6 .2.1.C.
  • Action
    The not ringing of the bell occurs quite frequently. The user must always observe the real-time dose information and the cumulative fluoroscopy time provided by the system. The fault condition is reset when a new patient is entered or when the system is restarted. Company code for field action: FCO72200285

Device

Angiography Equipment Allura Xper. Model (s): FD10 (floor); FD10 (ceiling); FD20 (ground); FD20 (...

Manufacturer

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