Events

Alerte De Sécurité sur temporary pacemakers and pacing system analysers

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Pace Medical Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-05-16
  • Date de publication de l'événement
    2014-05-16
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140516.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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

temporary pacemakers and pacing system analysers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Pace Medical temporary pacemakers and pacing system analysers
  • Manufacturer
    Pace Medical Inc

Manufacturer

Pace Medical Inc