Events

Alerta De Seguridad para cardiovit at-102 plus

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

¿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
    2017-02-08
  • Fecha de publicación del evento
    2017-02-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170208b.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: schiller medical cardiovit at-102 plus medical device manufacturer, schiller medical, has issued a medical device safety alert concerning its cardiovit at-102 plus (software version: 1.21; 1.22 or 1.23 and article number: 0.075000) it has recently come to the manufacturer’s attention that patient data mix-up may happen when the setting of “manual send” and “automatic erase after send” is chosen for the data transmission. according to the manufacturer, electrocardiography (ecg) data interchange only happens with this particular setting. all other settings are not affected. the occurrence is evaluated as rare, considering the limited number of incident reports in relation to the number of ecgs made per year and due to the fact that most customers use auto transmission, and additionally to the fact that data interchange is not likely to happen if the patient is released from the cables before the manual ecg transmission is started. the affected users are advised to check their stock and devices on the field to identify the software version of cardiovit at-102 plus. if the software version is either 1.21, 1.22 or 1.23, they need to take actions as recommended below. until receiving a new software version of cardiovit at-102 plus from the manufacturer, affected users are advises to take one of the following three settings to prevent the occurrence of the patient safety issue: automatic send with automatic erase of data after sending automatic send without automatic erase of data after sending manual send without automatic erase of data after sending the manufacturer will deliver a new software version to address this issue and will be released by february 2017. according to the manufacturer, the affected products are not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 8 february 2017.

Device

cardiovit at-102 plus
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: CARDIOVIT AT-102 Plus
  • Manufacturer
    Schiller Medical

Manufacturer

Schiller Medical