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Medical Device Alert: Legendair ventilator manufactured by Covidien (MDA/2011/098)

Document details:

Type: Medical Device Alert
Series No: MDA/2011/098
Audience: Healthcare professionals
Published: 5 October 2011 at 14:30
Format: Electronic only
Size: A4
Pages: 4
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Action

Ref: MDA/2011/098 | Issued: 5 October 2011 at 14:30

  1. England
  2. Northern Ireland
  3. Scotland
  4. Wales
  5. Device
  6. Problem
  7. Action
  8. Distribution
  9. Manufacturer contact
  10. Feedback

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/098 or 2011/005/012/291/007

Technical aspects
Louise Mulroy or Yasser Zayni
Medicines and Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7344/7238
Fax: 020 8754 3965

Email: louise.mulroy@mhra.gsi.gov.uk or yasser.zayni@mhra.gsi.gov.uk 

Clinical aspects
Nicola Lennard
Medicines and Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7126
Fax: 020 8754 3965

Email: nicola.lennard@mhra.gsi.gov.uk 

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices
Further information about CAS can be found on the CAS website (external link)

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900
Email: NIAIC@dhsspsni.gov.uk

http://www.dhsspsni.gov.uk/index/hea/niaic.htm

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722
Email: nss.iric@nhs.net

http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk

Legendair ventilatorLegendair ventilator manufactured by Covidien.

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

This is a portable ventilator, which can be used in a homecare environment. The
Field Safety NoticePDF file (opens in new window) (1074Kb) refers to a number of product codes but only devices with codes 4095701 and 4095901 are affected in the UK.

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 NoticePDF file (opens in new window) (1074Kb) (dated 20 May 2011) and acted on this information.

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 five 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.

  • To confirm that the performance of the audio alarm is within specification, carry out the additional test as detailed in the manufacturer’s Field Safety NoticePDF file (opens in new window) (1074Kb).
  • 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 NoticePDF file (opens in new window) (1074Kb).
  • 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 manufacturer.

Action by:
Staff responsible for maintaining or operating these devices.

This MDA has been sent to:

  • NHS trusts in England (chief executives)
  • Care Quality Commission (CQC) (Headquarters) for information
  • HSC trusts in Northern Ireland (chief executives)
  • NHS boards in Scotland (equipment co-ordinators)
  • Local authorities in Scotland (equipment co-ordinators)
  • NHS boards and trusts in Wales (chief executives)
  • Primary care trusts in England (chief executives) 
  • Social services in England (directors)

Onward distribution
Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

Clinical governance leads
EBME departments
Equipment stores
Hospital at home units
In-house maintenance staff
Medical directors
Neurology units
Nursing executive directors
Paediatric nurse specialists
Paediatricians
Palliative care teams
Respiratory nurse specialist
Respiratory physicians
Risk managers
Spinal rehabilitation units
Spinal units

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

  • Community hospitals
  • Community nurses
  • District nurses
  • Health visitors
  • Palliative care teams

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by: 

  • Care homes providing nursing care (adults)
  • Hospices
  • Hospitals in the independent sector
  • Private medical practitioners

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Amanda Woolven
4500 Parkway
Fareham
PO15 7NY

Tel: 01329 224 435
Email: Amanda.woolven@covidien.com 

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk 

Page last modified: 07 October 2011