Events

Alerte Ou Avis De Sécurité sur All Servo ventilators 300 and 300A with automode function

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Maquet Critical Care AB.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2009/020
  • Numéro de l'événement
    CON041410
  • Date
    2009-03-24
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON041410
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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).
  • Action
    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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    MHRA