Events

Alerta De Seguridad para Product name: Renasys GO Power Adapter and Power Cable Negative Wound Pressure Therapy - Portable - Product registration number on Anvisa: 80804050154 - Hazard Class: Class II - Affected Model (s): All serial number 144500875

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Smith & Nephew Comércio de Produtos Médicos Ltda..

¿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
    1837
  • Fecha
    2016-03-18
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The company describes that "after reviewing the complaints data related to external power units, smith & nephew has identified that some external power units may overheat and cause electric shock when used with renasys go negative pressure therapy . only certain external power units are affected by this problem. this field action only covers external power units and not renasys go negative pressure therapy pumps or the power cables that connect the external power supply unit to the power supply. ".
  • Acción
    Correction in field / exchange of external power supply units of RENASYS GO equipment. Type of field action: class III, field correction; II. Field Action Code: 001/2016; III. Recommendations to Users and Patients: a. Users are instructed to immediately disconnect all affected external power units from the power source. B. The pump will continue to ensure Negative Pressure Therapy treatment until the device's internal battery runs out. w. Users should switch to an unaffected external power unit while the device is in battery mode to prevent interruption of Negative Pressure therapy. Negative Pressure therapy will no longer be supplied by the pump as soon as the RENASYS GO internal battery runs out. d. If an unaffected external power supply is not available, patients should consult their health care provider to determine an alternative treatment. and. Users should not use non-Smith & Nephew external power units with the RENASYS GO Negative Pressure Therapy Pump. LETTER TO THE CUSTOMER IN ANNEX.

Device

Product name: Renasys GO Power Adapter and Power Cable Negative Wound Pressure Therapy - Portable...

Manufacturer

Smith & Nephew Comércio de Produtos Médicos Ltda.