Events

Alerte De Sécurité sur Merlin@Home Transmitter

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par St. Jude 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
    2012-06-27
  • Date de publication de l'événement
    2012-06-27
  • 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_20120627.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: st.Jude medical merlin@home transmitter the health canada posted a medical device recall notice concerning merlin@home transmitter, manufactured by st. jude medical, cardiac rhythm management system. the affected model number is ex1150. according to the manufacturer, there is potential for intermittent communication difficulties with these merlin@home transmitters due to an anomaly with a microcontroller chip in the transmitter. if the anomaly occurs, the patient's merlin@home transmitter will not be able to send data to the merlin.Net database. however, implanted device function is not affected. for details, please refer to health canada website http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 27 jun 2012.

Device

Merlin@Home Transmitter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: St. Jude Medical Merlin@Home Transmitter
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH