Events

Alerta De Seguridad para B20, B30 & B40 Patient Monitors

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

¿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
    2013-10-04
  • Fecha de publicación del evento
    2013-10-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131004.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: ge healthcare b20, b30 & b40 patient monitors the therapeutic goods administration (tga), australia has issued a medical device safety alert concerning b20, b30 & b40 patient monitors, manufactured by ge healthcare. the serial numbers of the affected products are identified as follows:- b20 - sgf11030001wa to sgf13176741wa (software version 1) b30 - sf309380033wa to sf313177120wa (software version 2) b40 - sg211210001wa to sg213172146wa (software version 1) b40 - sjf13010005wa to sjf13180144wa (software version 2) the b20, b30 and b40 patient monitors set the ecg filter setting incorrectly if the monitor starts with impedance respiration set in the on position. instead of the user selected filter, an additional 0.5 hz high pass filter is used. the additional 0.5 hz high pass filter causes changes to the ecg waveform morphology and incorrect display of st values. the st-elevation measurement can be under-estimated in this situation and treatment of the patient can be delayed. the manufacturer is providing users with work around instructions to follow until a software correction is available. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01027-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 october 2013.

Device

B20, B30 & B40 Patient Monitors
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE Healthcare B20, B30 & B40 Patient Monitors”
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare