Events

Alerte De Sécurité sur micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580

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.

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
    2012-04-30
  • 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_20120430a.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
    Field safety notice: pace medical micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580 it has come to our attention that medical device manufacturer, pace medical, inc. has initiated a field safety corrective action concerning micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580. the manufacturer has observed a small population of ref 4580 in which a component has not performed as well as expected. it has been reported to the manufacturer that some users of the device have encountered the failure of a mosfet which can affect output of the device. typical failure has been seen where output has been compromised on either the atrial or ventricular channel of the device. after reviewing two recent incident reports and following to “bench testing” of the device, the manufacturer has decided to make a voluntary, proactive decision to modify the product by changing a mosfet component. according to the manufacturer, the affected product is not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Pace Medical MICRO-PACE™ dual-chamber temporary cardiac pacemaker, REF 4580
  • Manufacturer
    Pace Medical

Manufacturer

Pace Medical