ALERT - Legendair ventilator manufactured by Covidien

Product codes of affected devices in the UK: 4095701 and 4095901.

The manufacturer has found that, in the event of a total mains power failure, the battery backup alarm may fail due to degradation of components necessary to power this alarm. This could result in either a total loss of the final battery alarm or a decrease in the volume or duration of the alarm.

The manufacturer has not had sufficient confirmation from users that they have received the Field Safety Notice (dated 20 May 2011) and acted on this information.

• To confirm that the performance of the audio alarm is within pecification, carry out the additional test as detailed in the manufacturer’s Field Safety Notice. This additional test should be completed as soon as possible, rather than waiting for the annual service.

• If the alarm fails, please follow the manufacturer’s instructions in the Field Safety Notice.

Action by • Until the test has been completed, the ventilator must be operated under mains power and with a fully-charged internal battery.

• Return the verification form to the Staff responsible for maintaining or operating manufacturer. these devices.

CAS deadlines Contact Action underway: 19 October 2011 Manufacturer Amanda Woolven Action complete: 02 November 2011 Covidien

Tel: 01329 224 435 Email: Amanda.woolven@covidien.com Medicines and Healthcare products Regulatory Agency Page 1 of 4 Issued: 05 October 2011 at 14:30 Ref: MDA/2011/098

Device This is a portable ventilator, which can be used in a homecare environment.

The Field Safety Notice refers to a number of product codes but only devices with codes 4095701 and 4095901 are affected in the UK.

Problem The final battery alarm, indicating that the ventilator is no longer functioning follows three low battery warning alarms: • Alarm 1 – when 5% of internal battery is remaining, a continuous alarm will sound until reconnected to the mains. • Alarm 2 – when 5 minutes is remaining. • Alarm 3 – when battery is almost depleted. • Alarm 4 (final) – when battery is depleted. However, a component failure could lead to a decrease in volume or duration of the final alarm, or no audible alarm at all.