Events

Alerta De Seguridad O Notificaciones De Seguridad para All Servo ventilators 300 and 300A with automode function

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Maquet Critical Care AB.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2009/020
  • Número del evento
    CON041410
  • Fecha
    2009-03-24
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON041410
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of inadequate ventilation of neonatal or paediatric patients without warning by any alarm. the mhra is aware of an incident where a reduced inspiration time occurred, with no alarm, during ventilation of a neonate with a servo ventilator 300a. the automode was on with the trigger level set to the minimum and the patient had no spontaneous breathing. the reduced inspiration time resulted in inadequate ventilation. when pressure control (pc) or pressure regulated volume control (prvc) ventilation is used with automode set to ‘on’ the ventilator cycles to expiration in the controlled mode if the airway pressure exceeds the set/calculated inspiratory pressure by more than 3 cm h2o. the purpose of this cycle off criterion is to provide a smooth transition from controlled to supported ventilation when the patient starts to trigger the ventilator, since this increase in pressure is interpreted as the patient working against the ventilator. this phenomenon only occurs with neonatal or paediatric patients with small tidal volumes and set, short inspiratory rise times during either pc or prvc ventilation. the probability of occurrence increases with larger, compressible volumes in the tubing system (including humidifier chamber) and with a lower resistance of the patient’s airways (including tracheal tube). the manufacturer issued a field safety notice on 15 december 2008 (see appendix - in pdf only).
  • Acción
    Identify if you have any Servo 300 or 300A ventilators that have an automode function. When using the automode function with either pressure control (PC) or pressure regulated volume control ventilation (PRVC) mode in the neonatal or paediatric patient range, ensure that: the set inspiratory rise time is in the range 7-10% the water level of the humidifier chamber is maintained according to the manufacturer’s recommendations. Ensure that users are aware of and act on Maquet’s Field Safety Notice.

Device

All Servo ventilators 300 and 300A with automode function
  • Modelo / Serial
  • Descripción del producto
    All Servo ventilators 300 and 300A with automode function. Manufactured by Maquet Critical Care AB (previously Siemens). The Servo ventilators 300 (SV300) and 300A (SV300A) are intended for general and critical care ventilation of adult, paediatric and neonatal patients. Affected ventilators are those with an automode function. Automode is a function where two consecutive breathing efforts from the patient will shift the ventilator status from control mode to a support mode. The ventilator will remain in the support mode as long as the patient keeps breathing; if the patient stops breathing the ventilator will shift back to the control mode. The Servo-I ventilator is not affected by this issue.
  • Manufacturer
    Maquet Critical Care AB

Manufacturer

Maquet Critical Care AB
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    MHRA