Events

Alerta De Seguridad para RPM Respiratory Gating System

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

¿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
    2013-04-08
  • Fecha de publicación del evento
    2013-04-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130408.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: varian rpm respiratory gating system medical device manufacturer, varian medical systems has issued a medical device safety alert concerning real-time position management (rpm) respiratory gating systemv1.7.5 with 3d option. an anomaly has been identified with the rpm respiratory gating system software version 1.7.5, 3d option. while operating with the 6-dot marker block, this version of rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions. trace inversion occurs when the breathing trace on the chart window moves in a phase opposite to the marker block movement. this event has been reported in an extremely limited number of times in the installed base, but users should be aware and monitor their displays carefully. the error may be reproduced if the rpm system is induced to frequently lose and re-acquire tracking of the 6-dot marker block during a calibration sequence, a reference session, or a single session after tracking has begun. in practice, this has been extremely rare. the root cause of the malfunction has been determined to lie within the smarttrack software library used only by rpm v1.7.5 with the 3d option. therefore, the manufacturer has developed a technical correction for this issue. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 8 april 2013.

Device

RPM Respiratory Gating System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian RPM Respiratory Gating System
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems