Alerta De Seguridad para Impulse Elite OCD

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • 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: airsep impulse elite ocd the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning impulse elite ocd, which is an electronic oxygen conserving device manufactured by airsep corporation. the affected model number is oc006-3 and the affected serial numbers are between 0088102 and 101360+. according to the tga, it has been determined that there is a weak spot in the solder joint at the pressure gauge which may cause the development of a gas leak from this area. in extreme cases, there is a small chance that the pressure gauge may suddenly fail resulting in an uncontrolled release of a small volume of high pressure oxygen accompanied by a large "bang" sound. the tga supplemented that end users are requested to notify their supplier if they have an affected device and the supplier will arrange for the replacement of the unit. meanwhile, the affected units can continue to be used in the interim. the affected users are advised to: listen for gas leaks emanating from the ocd. adjust the ocd on the cylinder valve. should the leak persist, discontinue use and contact customer service of their supplier, and avoid standing over or placing the head in close proximity to the pressure gauge. if this is required to read the gauge, then keep the duration of this inspection as short as possible. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00462-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 june 2013.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: AirSep Impulse Elite OCD
  • Manufacturer