Events

Alerta De Seguridad para ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por ConMed.

¿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
  • Fecha
    2016-05-20
  • Fecha de publicación del evento
    2016-05-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160520.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: conmed thermoguard plus abc paediatric dual dispersive electrodes the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning thermoguard plus abc paediatric dual dispersive electrodes [reference number: 7-383; lot codes: 141010x to 20150705x], manufactured by conmed. the thermogard dual dispersive electrode pads are not compatible with some brands of electrosurgical generators using “passive” cqm (contact quality monitoring) systems. whilst there have been no reports of injury or death, there is a possibility of a patient burn when used with a “passive” cqm electrosurgical generator. the manufacturer is advising users to inspect stock and discontinue use of affected devices. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00653-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 may 2016.

Device

ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: ConMed ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes
  • Manufacturer
    ConMed

Manufacturer

ConMed