Events

Alerta De Seguridad para AngioJet Ultra 5000A Console Foot Switch

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

¿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_20170208c.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: boston scientific angiojet ultra 5000a console foot switch medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its angiojet ultra 5000a console foot switch. the manufacturer has received field reports regarding the angiojet ultra 5000a console foot switch sticking during use resulting in an undesired continued operation of the device. if this situation occurs, perform the troubleshooting steps per the operator’s manual. an attempt can be made to manually release the footswitch, or turn the console off to deactivate the catheter. according to the manufacturer, there have been no reported patient adverse events as a result of these complaints. the complaint review shows that this issue results in a prolongation of the procedure in order to perform troubleshooting steps and remove the catheter. the most serious consequence from this issue could be the need to abort a procedure if the situation has not been resolved and alternative options are not available. if affected users noticed this issue with angiojet ultra 5000a console foot switch at their facility, they should discontinue use and contact the local sales representative. if the foot switch is operating correctly, no action is necessary. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 08 february 2017.

Device

AngioJet Ultra 5000A Console Foot Switch
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific AngioJet Ultra 5000A Console Foot Switch
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH