Events

Alerta De Seguridad para CHILDREN'S INCUBATORS C2HS ISOLETTE

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por HILL ROM AIR-SHIELDS A HILLEBRAND CO..

¿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
    26
  • Fecha
    2001-05-14
  • 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
    BRAZIL - COMPANY INSTRUCOM informs that the corrections have been implemented in the manufacturing line, therefore the product presents no risk to the patient or to the user.
  • Causa
    White layers of waste in the humidity evaporator reservoir were reported with these incubators. in a report, the waste occurs the tube that connects the camera to the reservoir. this problem persisted even after the sterile water is replaced by ag.
  • Acción
    IDENTIFY ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. REPORT USERS AND MAINTENANCE MANAGERS IN THEIR ALERT SETTING. THE MANUFACTURER AFFIRMS THAT THE RESERVOIR HAS BEEN MODIFIED BY PLACING A FLUORATED POLYMER COATING LAYER, SEALING, ON THE RESERVOIR ALUMINUM SURFACE TO PREVENT CORROSION AND AVOID WASTE FORMATION. THE MODIFIED RESERVOIR IS INCORPORATED IN ALL UNITS PRODUCED AS OF APRIL 21, 2000 AND IS AVAILABLE TO REPLACE IN UNITS WHICH NEED, HAVE RESIDUES, OR ARE NOT OPERATING. ECRI RECOMMENDS THE FOLLOWING: (1) NOTIFY YOUR PERSONNEL TO OBSERVE THAT WASTE AND WILL ALERT THESE POSSIBILITIES. REMEMBER ONLY WHAT DISTILLED WATER SHOULD BE USED. (2) IF DISTILLED WATER IS ONLY USED BUT WASTE WASTE TANKS, CONTACT THE MANUFACTURER TO REPLACE THE RESERVOIR [TELEPHONE: 0021-1-215-675-5200]. (3) EXAMINE THE CONDITION OF THE TUBES. PLEASE NOTE AND ALERT THAT THIS TUBE VERIFICATION MUST BE PART OF THE INSPECTION PROGRAM AND PREVENTIVE MAINTENANCE FOR EVERY 6 MONTHS.

Device

CHILDREN'S INCUBATORS C2HS ISOLETTE

Manufacturer

HILL ROM AIR-SHIELDS A HILLEBRAND CO.
  • Source
    ANVSANVISA