Events

Alerte De Sécurité sur HeartWare Ventricular Assist System Batteries

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par HeartWare 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
    2014-05-08
  • Date de publication de l'événement
    2014-05-08
  • 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_20140508.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: heartware ventricular assist system batteries the australia therapeutic goods administration (tga) posted a medical device safety alert concerning heartware ventricular assist system batteries manufactured by heartware inc. the affected product code is 1650. all heartware battery serial numbers are affected. the manufacturer has seen an increase in complaints related to both premature battery failure and routine battery handling. premature or unrecognised deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death. early recognition of premature battery depletion, patient training and close attention to recommended power management practices are crucial to reduce patient risk. therefore, the manufacturer is providing patients and health professionals with information to recognise batteries with less than two hours of run time, re-emphasise instruction on actions to take when battery alarms occur and reinforce proper power management. the manufacturer is closely monitoring the complaints to ensure that the heartware system functions as intended and to assess the effectiveness of the field correction. the manufacturer will continue to investigate prematurely depleting batteries and will take additional actions as appropriate. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00510-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 08 may 2014.

Device

HeartWare Ventricular Assist System Batteries
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: HeartWare Ventricular Assist System Batteries
  • Manufacturer
    HeartWare Inc

Manufacturer

HeartWare Inc
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH