Events

Safety Alert Or Field Safety Notices for SERVO-i ventilator system battery modules

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Maquet.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/037
  • Event Number
    CON282772
  • Date
    2013-06-06
  • Event Date Posted
    2013-06-06
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON282772?tabName=allTabs
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    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