Events

Alerta De Seguridad para MAQUET SERVO-air

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

¿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
    2017-10-10
  • Fecha de publicación del evento
    2017-10-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171010a.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: maquet servo-air the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a field safety notice concerning servo-air, manufactured by maquet [article number: 66 82 000]. all serial numbers with currently released software version 1.00.03 or older are affected. under certain conditions, the manufacturer has identified that an internal communication error might prevent the execution of the automatic failure handling process. as a consequence, ventilation will stop and a high priority alarm will be triggered. the manufacturer is aware of two instances where this issue has led to patient injury. according to the manufacturer, under normal circumstances, if a software-related error is detected, the system will resolve it automatically while ventilation continues uninterrupted. this issue will stop ventilation, with the safety and the expiratory valves open, thus allowing the patient to breathe freely, but without ventilator support. the high priority technical error alarms te43, te78, te80 and te81 will be activated simultaneously. a new system software version 2.01.02 that will correct this behavior is being developed. the manufacturer will initiate an immediate update of all affected servo-air units as soon as the system software version 2.01.02 is released. the servo-air ventilator can be used in accordance with the instructions for use, with extra attention to the following: never leave the patient unattended when connected to the ventilator system. make sure that a resuscitator is readily available. act as instructed on alarms. in case of a technical error te43, te78, te80, te81 replace the ventilator immediately and contact the manufacturer’s representative. for details, please refer to the following link: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-02-to-06-october-2017 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 october 2017.

Device

MAQUET SERVO-air
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: MAQUET SERVO-air
  • Manufacturer
    MAQUET

Manufacturer

MAQUET