Alerta De Seguridad para temporary pacemakers and pacing system analysers

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Pace Medical 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
    2014-05-16
  • Fecha de publicación del evento
    2014-05-16
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: pace medical temporary pacemakers and pacing system analysers the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert (mda) concerning temporary pacemakers and pacing system analysers, manufactured by pace medical inc. in april 2014, the subcontractor of the manufacturer was audited by its notified body, with the regulatory agency present as the observer. the audit found significant quality system failings relating to processes for complaint handling, post-market surveillance and vigilance, which included failures to implement corrective actions agreed at previous audits. as a result of this, on 9 april, the notified body suspended the ec-certification issued to the manufacturer for all devices, except the pacing cables. any remaining pace medical devices purchased by distributors before this date can still be sold to uk hospitals. servicing of devices already in the field is unaffected by the suspension of the ec certificate. according to the mhra mda, as the manufacturer only holds validation data to confirm compatibility of their own cables with their pacemakers, users are advised to continue to make a risk-based decision on the use of alternative, reusable or disposable cables or heart wires, based on availability and clinical need. furthermore, users should consult with the manufacturer or relevant distributors for further information on cable availability, where necessary. the manufacturer is working with its notified body to prepare a corrective action plan to address the identified issues. the notified body will need to complete follow-up audits of the manufacturer’s actions before the ec-certification can be restored. for details, please refer to the following link: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00536-2 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 16 may 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Pace Medical temporary pacemakers and pacing system analysers
  • Manufacturer

Manufacturer