Events

Alerta De Seguridad para UROLOGICAL TABLES

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿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
    101
  • Fecha
    2001-06-30
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    An ecri member hospital reported a fire on a urological table, which probably occurred due to service materials (eg, documents, software, spare parts, tools) have been stored in a static proof in an electrical framework within the table and heat resulting from the circuit inflamated the plastic of the service materials and the stage-proofed bag.
  • Acción
    ACTION REQUIRED: (NOTE: READ THE ORIGINAL REPORT BELOW UNDERSTANDING THE REASON FOR THE FOLLOWING RECOMMENDATIONS.) ECRI RECOMMENDS THAT: (1) ALERGE USERS, SERVICE PERSONNEL AND OTHER EMPLOYEE MEMBERS ON THE PROBLEM AND THE ECRI REPORT. (2) DO NOT STORE SERVICE MATERIAL INSIDE THE EQUIPMENT, UNLESS SPECIAL COMPARTMENT IS FOR SUCH MATERIALS. (3) SAVE THE SERVICE MATERIAL IN A CENTRAL SITE, AS DESCRIBED IN THE INSTALLATION EQUIPMENT CONTROL PROGRAM. (4) IF THE SERVICE MATERIAL HAS TO BE KEPT WITH EQUIPMENT WHICH DOES NOT HAVE AN APPROPRIATE SITE FOR STORAGE, ATTACH A PLASTIC COMPARTMENT OR CONTAINER ON THE EXTERNAL SIDE OF THE EQUIPMENT BOX. MAKE SURE THAT THE PLASTIC COMPARTMENT OR THE CONTAINER IS KEPT FROM AIR CIRCULATORS, CONTROL SURFACES, OR SURFACES THAT COULD BE CHARGED. FOR FURTHER INFORMATION, CONTACT RICHEMOND'S AL, ECRI, BY PHONE (610) 825-6000, RAMAL 5187.

Device

UROLOGICAL TABLES
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA