Events

Alerta De Seguridad para FRED easy

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

¿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
    2017-02-06
  • Fecha de publicación del evento
    2017-02-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170206c.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: schiller medical sas fred easy the health sciences authority (hsa) has issued a medical device safety alert concerning fred easy, manufactured by schiller medical sas [reference: 4-07-0001; lot number hyb 16-0056, hyb 16-0057, hyb 16-0058 and hyb 16-0059; between october 1, 2016 and january 15, 2017]. according to the manufacturer, users have reported some new batteries causing the failure "battery empty" when inserted into a defibrillator fred easy. batteries with this fault cannot be used. the fault is detected automatically by the fred easy when the battery is inserted into the device. the batteries of these lots must be tested, using the procedure described below, to verify that they can be used in their fred easy: insert the battery into fred easy (see section 3.1 "inserting the battery" in the fred easy user manual). the unit performs its self-test. at the end of the self-test, it shuts down and its green led flashes: in this case, the battery is free from defects and can be used without limitation. however, if after the self-test of fred easy the green light remains off and the display shows: the battery is defective. in this case, contact schiller distributor immediately, to get replacement. for details, please refer to the hsa website: http://www.Hsa.Gov.Sg/content/hsa/en/health_products_regulation/medical_devices/product_owners_fsn/2017/january.Html if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 february 2017.

Device

FRED easy
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Schiller Medical SAS FRED easy
  • Manufacturer
    Schiller Medical SAS

Manufacturer

Schiller Medical SAS