Alerta De Seguridad para Grab'n Go Vantage Portable Oxygen Cylinder Unit

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Praxair 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
  • Fecha
    2013-01-04
  • Fecha de publicación del evento
    2013-01-04
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: praxair grab'n go vantage portable oxygen cylinder unit medical device manufacturer, praxair inc. has issued a medical device safety alert concerning grab ‘n go vantage portable oxygen cylinder unit (catalogue no.: ox-m-aegngvntg (us and canada) and wesprx-9500 (global). the manufacturer has initiated a field safety corrective action for the grab'n go vantage portable oxygen cylinder unit because fires may occur inside the cylinder unit causing the wall of the unit to break and release oxygen. the fires are self extinguishing and may be caused by physical impact such as dropping or knocking over the cylinder unit. if a fire occurs, users may experience burns or a lack of oxygen (hypoxia). this product may cause serious adverse health consequences, including death. customers were instructed to send the affected device to the manufacturer for servicing and refilling after use in accordance with their normal processes. for further details, please refer to the fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-0525-2013&w=01022013&lang=eng http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm333846.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 04 january 2013.

Device

  • Modelo / Serial
  • Clasificación del producto
  • Descripción del producto
    Medical Device Safety Alert: Praxair Grab'n Go Vantage Portable Oxygen Cylinder Unit
  • Manufacturer

Manufacturer