SERVO-i ventilator system battery modules 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2013/037

CON282772

2013-06-06

2013-06-06

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON282772?tabName=allTabs

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.

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.