Events

Alerta De Seguridad para Ergolet Hera II Bathing and Toilet Chair

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

¿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
    2012-04-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120420a.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
    Field safety notice: ergolet hera ii bathing and toilet chair medical device manufacturer, ergolet aps, has issued an urgent field safety notice concerning ergolet hera ii with model numbers 041-00250, 041-00255, 041-00256, 041-00280, 041-00281 and serial numbers 1379 to 2180. after an incident and several claims regarding broken gas springs on the hera ii, ergolet has conducted a risk analysis and decided that replacement of the gas spring is necessary. according to ergolet, the back fixture of the gas spring has been known to break after a significant time of use, resulting in the chair to tilt backwards. if a patient is seated in the chair during this malfunction, head or neck injury may be resulted due to the sudden backwards movement. the gas spring has been updated with a reinforced back fixture on products with serial number 2181 and higher. the updated gas spring is compatible to all hera ii and is now available for replacement. according to the manufacturer, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Ergolet Hera II Bathing and Toilet Chair
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ergolet Hera II Bathing and Toilet Chair
  • Manufacturer
    Ergolet ApS

Manufacturer

Ergolet ApS