Events

Alerta De Seguridad para MAQUET Servo Humidifier 163

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Arrow International 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
    2015-02-23
  • Fecha de publicación del evento
    2015-02-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150223b.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: maquet servo humidifier 163 the united states food and drug administration (fda) posted a medical device safety alert concerning components of maquet servo humidifier 163 [model number: 01-06-8125-8; catalogue number: xkc01-06-8125-8; batch numbers: 201321, 201323, and 201324], manufactured by arrow international inc. the recall was initiated because of connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. if leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur. for details, please refer to the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1008-2015&w=02182015&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 february 2015.

Device

MAQUET Servo Humidifier 163
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: MAQUET Servo Humidifier 163
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc