Events

Alerta De Seguridad para Platinum Oxygen Concentrator

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

¿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
    2015-05-11
  • Fecha de publicación del evento
    2015-05-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150511.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: invacare platinum oxygen concentrator australian therapeutic goods administration (tga) posted a medical device safety alert concerning invacare platinum oxygen concentrator, manufactured by invacare. the affected model numbers are irc9lxo2awq , irc5lx02aw, irc5lxaw. the manufacturer has learned that the pressure sensitive interrupter (psi) design for the compressor motor start/run capacitor by one supplier could lead to rupture. that capacitor in the oxygen concentrator has an internal pressure relief component (the psi) which may not operate as intended permitting the capacitor to rupture in certain circumstances. these capacitors were utilised in production from march 2010 to august 2012 at one of their manufacturing sites. if the psi does not function to relieve the heat and pressure due to a short circuit within the capacitor, then the pressure can cause a rupture in the seam between the housing and the end plate. if the rupture occurs, the oil may be expelled from the capacitor which may result in a fire hazard. the manufacturer is providing instruction on how to identify if an affected capacitor is present in the oxygenator. if present, end users are requested to contact their distributor to arrange for a technician to replace the capacitor. for details, please refer to the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00383-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 may 2015.

Device

Platinum Oxygen Concentrator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Invacare Platinum Oxygen Concentrator
  • Manufacturer
    Invacare

Manufacturer

Invacare