Events

Alerta De Seguridad para Oxygen Concentrators

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

¿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
    2012-06-04
  • Fecha de publicación del evento
    2012-06-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120604a.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: nidek medical oxygen concentrators the united states food and drug administration (fda) issued a class i recall concerning oxygen concentrators manufactured by nidek medical products with model numbers as follows [serial numbers 042-10000 through 102-07044]: nidek medical mark5 nuvo 8 std, 115 v~60hz - 500w. nidek medical mark5 nuvo 8 /ocsi, 230 v~50/60hz - 420 w. nidek medical nuvo lite model 525 ocsi, 115v -60hz - 330w. nidek medical nuvo lite model 520 std, 115v - 60hz - 330w. nidek medical nuvo lite model 925 ocsi, 230v - 50hz - 300w. nidek medical mark5 nuvo / m5c5, 115 v ~60hz - 410 w. nidek medical m5c5/ mark5 nuvo/std, 230 v~50/60 hz - 420 w. nidek medical nuvo lite model 925 ocsi, 3lpm 230v - 60hz - 280w. nidek medical m5c5/ mark5 nuvo/ocsi, 230 v~50/60 hz -420 w. according to the fda, the reason of this recall was due to capacitor failure which may result in a fire hazard and loss of supplemental oxygen supply. according to the local suppliers, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 4 june 2012.

Device

Oxygen Concentrators

Manufacturer

Nidek Medical Products