Events

Alerta De Seguridad para OxyTOTE Valve Integrated Pressure Regulators

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Western / Scott Fetzer Co.

¿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
    2015-02-02
  • Fecha de publicación del evento
    2015-02-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150202.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: western / scott fetzer co. oxytote valve integrated pressure regulators health canada posted a medical device safety alert concerning oxytote valve integrated pressure regulators (viprs) [model numbers: mnr-600, mns-603, mtr-500, mtr-700, mts-501, mts-502, mts-503], manufactured by western / scott fetzer co. the manufacturer decided to initiate this recall based on reports of ignition events involving oxytote valve integrated pressure regulators (viprs) and the subsequent investigations into those events. based on the investigations, the manufacturer has become aware of the possibility of ignition and rupture (i.E., explosion) of the compressed gas oxygen cylinder, which can cause serious injury and/or death. for details, please refer to the following health canada website: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2015/43563r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 february 2015.

Device

OxyTOTE Valve Integrated Pressure Regulators

Manufacturer

Western / Scott Fetzer Co