Events

Alerta De Seguridad para HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery

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
    2015-12-28
  • Fecha de publicación del evento
    2015-12-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151228a.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 hvad controller ac adapter and heartware hvad battery the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning heartware hvad controller ac adapter and heartware hvad battery manufactured by heartware inc. the affected products are identified as follows: controller ac adapter: product code: 1430xx; serial numbers: cac000001 to cac005796 hvad battery: product code: 1650xx and a00035; serial numbers: bat000001 to bat199999 according to the alert, heartware ac adapters with the above serial numbers are vulnerable to power grid surges above 220 volts. if an ac adapter fails, the patient’s controller will alarm and automatically switch to the other power source. if patients follow the manufacturer’s patient manual, there are no elevated risks to health. however, if a patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a failed ac adapter, the system could lose power, which may lead to serious injury or death. there have been complaints related to earlier than expected battery depletion for batteries with serial numbers bat000001 to bat199999. premature or unrecognised battery depletion may pose a risk to the patient, if the patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a depleted battery. the manufacturer is advising healthcare professionals to identify and quarantine the affected units in hospital inventory and arrange for current patients to bring their ac adapters and batteries to a clinic as soon as possible (at least within the next three months), with urgency dependent upon individual patient circumstances. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-01261-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 december 2015.

Device

HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery
  • 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