Events

Alerta De Seguridad para BVM (Bag-Valve-Mask) Manual Resuscitation Systems

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

¿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
    2018-01-09
  • Fecha de publicación del evento
    2018-01-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180109a.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: intersurgical ltd bvm (bag-valve-mask) manual resuscitation systems the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a field safety notice concerning bvm (bag-valve-mask) manual resuscitation systems, manufactured by intersurgical ltd. the affected devices are identified as the following:- reference numbers (lot numbers): 7150000 (363791, 370252, 370751, 371638, 372887, 372894, 375508) 7151000 (364909, 370253, 371091, 371639, 372886, 372890, 375711) 7152000 (363792, 364270, 364923, 365216, 370266, 370752, 371640, 371656, 372888, 372889, 372893, 373638, 373639, 375411) 7152005 (31753284, 31756956, 31757575) 7152006 (31660106, 31753127, 31756716, 31757576, 31758289) 7152007 (371092) 7152012 (31753733, 31756957) 7153000 (363793, 370738, 371907, 372892, 375509) 7153008 (31753734) 7154000 (370753, 372367) a manufacturing fault has been identified with the intersurgical bvm manual resuscitation system, which could result in the directional valves positioned on the ‘back plate’ of the self-inflating bag being orientated incorrectly. the incorrect orientation of the directional valves could result in the bvm manual system becoming over pressurised, which could result in patient barotrauma. according to the manufacturer, bvm manual resuscitation systems with alternative directional valves configuration positioned on the ‘back plate’ are not affected by this fsn and are safe to use. affected users are instructed to quarantine and stop the use of all affected devices. if no suitable replacement is available, users should check the orientation of the valves on the back plate of the self-inflating bag and ensure they are orientated correctly. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-2-to-5-january-2018 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 09 january 2018.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Intersurgical Ltd BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Manufacturer
    Intersurgical Ltd

Manufacturer

Intersurgical Ltd