Events

Alerta De Seguridad para 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.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1744
  • Fecha
    2015-11-18
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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.
  • Acción
    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.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA