Events

Alerta De Seguridad para HeartWare Ventricular Assist System Batteries

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por HeartWare 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
    2014-05-08
  • Fecha de publicación del evento
    2014-05-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140508.html
  • 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: 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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: HeartWare Ventricular Assist System Batteries
  • Manufacturer
    HeartWare Inc

Manufacturer

HeartWare Inc
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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