Events

Alerta De Seguridad para Corpatch Easy Pediatric

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

¿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
    2015-05-11
  • Fecha de publicación del evento
    2015-05-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150511a.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: leonhard lang corpatch easy pediatric australian therapeutic goods administration (tga) posted a medical device safety alert concerning corpatch easy pediatric (defibrillator electrodes), manufactured by leonhard lang gmbh. the affected product code is cp-5120.2 with lot numbers 30708-0777, 30822-0778, 31009-0773, 31121-0774, 40107-0771, 40213-0774, 40222-0773, 40320-0770, 40321-0770, 40324-0773, 40522-0779, 40704-0776, 40808-0773, 40923-0776, 41021-0778 the manufacturer’s internal investigation showed that during the use of these defibrillation electrodes, a possibility for arcing and a resulting malfunction exists. this malfunction can occur with defibrillation electrodes that are older than 2 years. this could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all. the precise cause for this is still under investigation. product replacement is on-going. for details, please refer to the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00388-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 may 2015.

Device

Corpatch Easy Pediatric
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Leonhard Lang Corpatch Easy Pediatric
  • Manufacturer
    Leonhard Lang GmbH

Manufacturer

Leonhard Lang GmbH