Events

Alerta De Seguridad para ASSEMBLY EQUIPMENT FOR: (1) CONTRAST INJECTORS, (2) EXPLANATION LIGHTS, (3) PHOTOTHERAPY UNITS, (4) RADIATION PROTECTORS IDENTIFIER:

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
    130
  • Fecha
    2000-09-22
  • 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
    Ecri has received failure reports from the assembly equipment which result in the equipment collapse or in the injury / involvement of patients or team members. fault reports included cracking of arm bracket or bracket of bracket machine. ecri affirms that these faults of the mounting equipment are generally resulting from inadequate decisions of installation, defective equipment or lower quality, misuse of equipment or wear and normal break.
  • Acción
    ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) REPORT TO EMPLOYEES THAT ASSEMBLING EQUIPMENT MAY FAIL AND CAUSE CORPORATE INJURY (2) DEFINE WHICH DEPARTMENT SHALL BE RESPONSIBLE FOR ROUTINE INSPECTIONS AND PREVENTIVE MAINTENANCE, AND REPORT THE EVIDENCE OF DAMAGE TO ASSEMBLY EQUIPMENT A THIS DEPARTMENT. (3) REPORT TO EMPLOYEES THAT THE ASSEMBLY EQUIPMENT MAY BE DAMAGED BY ITS BRUSK / UNUSED USE AND THAT THIS MUST BE HANDLED AS CAREFULLY AS MUCH AS THE MEDICAL EQUIPMENT AFFECTED IN IT. (4) INSPECT THE INSTALLATION OF THE MOUNTING EQUIPMENT TO ENSURE THAT STRUCTURES AND SUITABLE COMPONENTS ARE USED. (5) TURN THE ASSEMBLY EQUIPMENT INSPECTION PART OF THE INSPECTION ROUTINE OF ITS INSTALLATIONS AND ITS PREVENTIVE MAINTENANCE PROGRAM

Device

ASSEMBLY EQUIPMENT FOR: (1) CONTRAST INJECTORS, (2) EXPLANATION LIGHTS, (3) PHOTOTHERAPY UNITS, (...
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA