Alerta De Seguridad para Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E; CardioVive 92532 and 92533; and CardioLife 9200G and 9231

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Cardiac Science Corporation.

¿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
    2012-01-31
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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
    Press release
  • Causa
    Recall of cardiac science automated external defibrillators the department of health (dh) today (january 31) endorsed a local medical device supplier, pacific medical systems ltd's recall of a certain number of automated external defibrillators (aeds) made by a us manufacturer, cardiac science corporation, due to a possible failure in their delivery of defibrillation therapy. in fact, the recall is first initiated by cardiac science corporation in the us after it has detected through routine quality control that certain of its aeds made between july 1 and december 30, 2011 may not be able to perform. no report of rescue being impacted has been received anywhere in the world thus far. "according to cardiac science corporation, the affected models are powerheart 9300a, 9300e, 9300p, 9390a, and 9390e; cardiovive 92532 and 92533; and cardiolife 9200g and 9231," a dh spokesman quoted. "investigation by cardiac science corporation thus far reveals that the failure is likely due to a defect in a component of the circuit board which is amendable to corrective actions in the factory," the spokesman explained. pacific medical systems ltd reported that its sales record shows that they have imported some 135 involved devices into hong kong for supply to various users including dh. it will get in touch with affected customers to facilitate the return of the aeds for correction. in addition, the supplier has also set up a phone hotline at 2108 4005 for enquiries. "for the occasional customers who may have one of cardiac science corporation's aeds in hand and are uncertain about their status, they can visit the manufacturer's website at www.Cardiacscience.Com/aed210 to check by keying in the serial number marked at the back of individual devices," the spokesman elaborated. dh will be monitoring both the recall and in particular, the corrective action to be taken by pacific medical systems ltd. ends.

Device

Manufacturer