Events

Alerta De Seguridad para Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532 and 92533

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
    2009-11-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20091119.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
    Press release
  • Causa
    Field correction of automated external defibrillators the department of health (dh) today (november 18) alerted the public of a voluntary field correction by the manufacturer and supplier of two series of automated external defibrillator (aed)which may fail to deliver therapy during a resuscitation attempt. the affected models are powerheart 9300a, 9300c, 9300d, 9300e, 9300p, 9390a, 9390e, and cardiovive 92531, 92532 and 92533. the manufacturer, cardiac science corporation, estimated that one in 75,000 aeds manufactured between august 2003 and august 2009 may suffer the failure. a software update will be available by may 2010 to fix the problem. the company advises users to keep their aeds in service and follow the normal testing and maintenance procedures. about 262 aed of the two series of models have been sold to 157 users in hong kong. the local sole supplier of the affected aed, pacific medical systems ltd, could be contacted at 2108 4005 for advice. “users should follow the recommendations of the manufacturer and make contingency provisions in case the aed could not deliver therapy,” a spokesman for the department said. “the department had alerted the hospital authority, private hospitals, nursing homes, relevant institutions and medical association of the voluntary field action. “so far, no reports on adverse events arising from this issue have been received. “the department will closely monitor this field correction,” he said. ends/wednesday, november 18, 2009.

Device

Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532 and 92533
  • Modelo / Serial
  • Descripción del producto
    Press release: Field Correction of Automated External Defibrillators
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation