SN 2002(08) - Eastleigh apnoea respiration monitor RE200

Please note that contact names and/or numbers may have changed since this notice was published. If you need to contact us about a particular notice, please call on 020 7084 3272 or e-mail dts@mhra.gsi.gov.uk quoting the reference number and title of the notice.
_________________________________

 March 2002

MANUFACTURER/SUPPLIER
Ferraris Medical Limited, previously NH Eastwood and Son Limited.

PROBLEM
An apnoea monitor failed to detect that an incubated 1kg premature baby had stopped breathing, due to the sensor pad being placed on top of the mattress.

For the attention of:

Health Authorities (England) - Chief Executives
NHS Trusts (England) - Chief Executives
Primary Care Trusts (England) - Chief Executives

ACTION
All users should ensure that:-

• The sensor pad is placed UNDER the mattress beneath the baby.
• If the breath light on the monitor does not indicate the baby's breathing with the sensor under the mattress, the monitor is NOT to be used.
• The monitor is NOT to be used on babies weighing less than 1kg.

DISTRIBUTION REQUIRED
Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:

TRUSTS to:

• Liaison Officers (for onward distribution)
• Neonatal Intensive Care Units, NICU
• Special Care Baby Units, SCBU
• Maternity Units
• Labour/Delivery Suites

HEALTH AUTHORITIES to:

• Liaison Officers (for onward distribution)
• Chairs of Primary Care Groups
• General Medical Practitioners
• Practice Nurses
• Specialist Children's Nurses
• Midwives and Community Midwives
• Health Visitors
• Hospitals in the Independent Sector

PRIMARY CARE TRUSTS to:

• Liaison Officers (for onward distribution)

BACKGROUND

a) The RE200 apnoea/respiration monitor is an electronic monitoring system that detects breathing movement. It alarms after a delay following cessation of these movements. The flat pressure sensitive pad detects respiration movements through the mattress (20 to 50 mm thick).

b) MDA was informed of an incident where an RE200 apnoea monitor failed to detect that a 1kg premature baby, being nursed in an incubator, had stopped breathing. The baby's heart rate had dropped to 60 beats per minute (bpm) at the time of the discovery.

c) The sensor had been placed on top of the mattress under a sheepskin. In this position the sensor is less reliable being much more sensitive and likely to be affected by other non-breathing vibration.

d) Although the cause of the 'failure to alarm' could not be determined, a possible explanation is that the sensor may have responded to the baby's low heartbeat or other movement. Breathing had stopped and the heart rate had dropped from 160 bpm to a rate similar to normal breathing. Without the attenuation of the mattress it is possible that the sensor detected the heartbeat as breathing movement, which delayed the onset of the alarm.

e) As a result of this incident the manufacturer has issued revised user instructions. These instructions include the following Important Information:

PLEASE READ THIS INSTRUCTION LEAFLET CAREFULLY BEFORE USING THE EASTLEIGH RE200/R200C APNOEA MONITORS.

1. The monitor is for use by or under the guidance of medical and nursing professionals. When the RE200 monitor is being used at home, it should
only be with the direction and knowledge of medical personnel.

2. Care should be taken to ensure that external vibration or movement does not affect the monitor and cause spurious signals delaying the alarm. This may be achieved by ensuring that the alarm DOES sound, after installation, but prior to the baby being placed in the cot/incubator.

3. The sensor pad must be placed UNDER the mattress beneath the baby. If sensing is unachievable through mattress DO NOT USE the monitor.

4. The monitor does not prevent cessation of breathing - nor does it provide any stimulus to restore breathing, other than an audible warning alarm. Also note that this monitor is NOT recommended for use on babies less than 1 kg in weight.

5. Contact your distributor or manufacturers, Ferraris Medical Ltd. immediately, if there is any cause for concern in the operation of the monitor.

6. The monitor is NOT suitable for cars or other transport where there is movement.

ENQUIRIES

Enquiries to the MHRA should quote reference number 20010425.012-14

© Crown Copyright 2002