Events

Alerte Ou Avis De Sécurité sur SERVO-i ventilator system battery modules

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.

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/2013/037
  • Numéro de l'événement
    CON282772
  • Date
    2013-06-06
  • Date de publication de l'événement
    2013-06-06
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON282772?tabName=allTabs
  • 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 early or unexpected loss of ventilation due to certain battery modules having a shorter than specified run time. the mhra is aware of an incident where a servo-i ventilator system used in conjunction with an affected battery module shut down unexpectedly. in most cases the servo-i ventilator system will provide the user with a series of visual warnings and audible alarms before ventilation is lost. however, due to earlier than expected battery depletion, there is a possibility that ventilation may be lost without the normal sequence of alarms. in the case of a sudden loss of ventilation due to premature battery depletion, the servo-i ventilator system will enter a state with valves open and an audible alarm will sound for a period of two minutes. immediate intervention will be required to preserve adequate patient ventilation. this situation will not arise when the servo-i ventilator system is being powered either from a mains outlet or by unaffected batteries.
  • Action
    Be aware that Maquet has issued an updated Field Safety Notice dated 29 April 2013, which supersedes the Field Safety Notice dated 11 March 2013. Follow the advice given in the updated Field Safety Notice – contact Maquet to arrange for appropriate replacement battery modules (free of charge) and ensure that these are installed immediately. Users should re-familiarise themselves with the instructions for use and in particular: always respond to battery related warnings and alarms and be aware of the alarm sequence ensure a minimum of two battery modules are installed at all times ensure sufficient resuscitation equipment is available at all times only use the SERVO-i ventilator system for inter-hospital transport where the appropriate modification kit has been fitted. Immediately identify affected battery modules and contact Maquet to receive one free battery module per SERVO-i ventilator system. Additionally, all affected battery modules that have generated a ‘Replace battery’ alarm within 30 months of the date of manufacturer (see diagram above) will be replaced free of charge. In the event of ‘Limited battery capacity’, ‘No battery capacity’, ‘Low battery voltage’ and ‘Replace battery’ alarms, immediately connect the SERVO-i ventilator system to a mains outlet.

Device

SERVO-i ventilator system battery modules
  • Modèle / numéro de série
  • Description du dispositif
    SERVO-i ventilator system battery modules. Part number 6487180. Product codes 1005-1243 (inclusive) and manufactured from 01/02/2010 to 25/10/2012.
  • Manufacturer
    Maquet

Manufacturer

Maquet
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    MHRA