Events

Alerta De Seguridad para td-synergy software version 11.31.c

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

¿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
    2012-10-19
  • Fecha de publicación del evento
    2012-10-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121019a.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: technidata td-synergy software version 11.31.C medical device manufacturer, technidata s.A.S, has initiated a medical device field safety corrective action concerning td-synergy with software version 11.31.C. according to the manufacturer, a software defect has been identified. in certain conditions, results which have not been clinically validated are printed on the cumulative result printouts. the defect only applies to sites using cumulative result reports by department. if the following sequence of events takes place, results which have not been clinically validated, can be printed on the cumulative result printouts. if a request r1 is created for a patient p1 and if this request includes a test t1 where a result has to be validated; if a new request r2 is created for the same patient p1 and if the results of r2 request tests do not need to be clinically validated or are clinically validated before r1 request tests; then the printout of the cumulative report for request r2 results is triggered, including r1 request results with a t1 test which has not been clinically validated. according to the manufacturer, the affected device was distributed in hong kong and the software correction has already been implemented. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 october 2012.

Device

td-synergy software version 11.31.c
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: TECHNIDATA TD-Synergy Software Version 11.31.C
  • Manufacturer
    TECHNIDATA S.A.S

Manufacturer

TECHNIDATA S.A.S