Events

Alerta De Seguridad para (Camara Range) / E.CAM Signature Series, record 10234230040, risk class III, lots / series: 550; 588; 1017; 3002; 3006; 3051; 4004; 4019; 4022; 5017; 5034; 5155; 7006; 7016; 7086; 7507; 8011; 8019; 8575; 8576; 8671; 9002; 9036; 10012. e.cam systems installed before December 31, 2004.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Ltda.; Siemens Medical Solutions USA, Inc..

¿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
    1651
  • Fecha
    2015-07-27
  • 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
    In addition to touch-key failure, enabling an e-stop or a system power failure between 0.05 and 0.1 seconds after the start of the movement, may cause this fault to occur. Even so, the record holder recommends reliably emergency stop.
  • Causa
    According to the record holder there is an account of unintentional movement of the sensor. the main cause of this movement was determined as a simultaneous failure of two components, the radial brake circuit and the touch keypad. this combination of failures resulted in shaft brake inefficiency, which gave rise to sensor movement.
  • Acción
    The registration company directs customers to continue to use the equipment. It is recommended to observe the patient during the examination. The company has developed and will install an improved brake control circuit to correct this condition. You should ensure that this safety information is included in the instructions for use of the system. As usual, Siemens recommends observing the patient during the exams. If difficulties occur or a fault occurs while performing the daily touch-tone test, it is recommended to discontinue use and contact Siemens Technical Support. If unintended movement of the sensor is observed, remove the patient, interrupt the use of the system and contact Technical Assistance.

Device

(Camara Range) / E.CAM Signature Series, record 10234230040, risk class III, lots / series: 550; ...

Manufacturer

Siemens Ltda.; Siemens Medical Solutions USA, Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA