Alerta De Seguridad para VersaCare Bed

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

¿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
    2012-08-29
  • Fecha de publicación del evento
    2012-08-29
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: hill-rom versacare bed medical device manufacturer, hill-rom, has issued a medical device safety alert concerning versacare bed (revision e through j, serial number h345ad5880 through n138al9061). according to the manufacturer, hill-rom versacare bed has a built-in safety feature intended to protect the patient under certain conditions where bed movement could cause harm. this functional lockout feature is designed to disable the bed. however, the manufacturer has received complaints that the lockout is occurring on the bed of the captioned model when it should not. after an extensive review of this issue, the manufacturer has determined that the majority of these lockouts are related to technical problem on the printed circuit (pc) board within each versacare bed siderail. the manufacturer has identified the root cause to an intermittent connection between a chip and socket on the pc board. the manufacturer will provide a correction for the chip/socket problem which involves replacement of the pc boards in both head-end siderails. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 august 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hill-Rom VersaCare Bed
  • Manufacturer

Manufacturer