�The Medicines and Healthcare products Regulatory Agency (MHRA) is asking parents and carers to check their 'Baby Sleepsafe' monitors, manufactured by Axminster Electronics Ltd, after concerns that the device, if ever dropped, may afterwards fail to monitor a baby's breathing.
A batch of AxminsteR Baby SleepSafe (Model AE 010 M) monitors was supplied with defective battery terminals, which crataegus laevigata fail if the monitor has been dropped. The battery terminals should be fitted with coil springs, to see to it good liaison with the batteries. Monitors with the serial book of Numbers between 001360 and 001660 should be returned to the producer for an upgrade.
The device is connected to a sensor pad located under the mattress, and is intended to monitor the breathing movements of a baby. If a baby stops ventilation for 20 seconds an alarm should sound. These monitors ar primarily intentional for enjoyment in the home and are besides used in some neonatal intensive care and special care baby units.
Other batches of the monitors ar not affected as they were supplied with barrage contacts made from a more resilient material and/or with coil spring contacts.
This warning is for parents and carers who may have these monitors at home. The devices were supplied three to four years agone and are usually exploited to monitor a baby's breathing up to one year old. The worry is that these monitors could be used on siblings or passed on to relatives or friends for use on their babies.
The producer has contacted those hospitals to whom they own supplied the monitors straight off and requested these monitors for upgrading.
Clive Bray, Director of Device Technology and Safety at the MHRA said, 'The MHRA's advice to parents is to firstly check the nonparallel number, printed on the back of the monitor, above the battery compartment . If the number is between 001360 and 001660 then you should send the monitor back to the manufacturer. Also see the battery terminals to make sure they are applying firm pressure to the batteries and are fitted with coil springs.
People can report any rubber related issues concerning medical devices to the MHRA by calling our Adverse Incident Hotline on 020 7084 3080 or logging on to the MHRA website at http://www.mhra.gov.uk, selecting "Report medical devices inauspicious incidents" and following the instruction on the screen.
Notes
The MHRA has received no incident reports about the AxminsteR Baby SleepSafe (Model AE 010 M) whilst in use.
Damage can likewise occur if the batteries are fitted incorrectly and the contacts are bent beyond their elastic limit point. If the monitor is sent through the post with the batteries installed, damage toilet be caused to the terminal. (Note: - The manufacturer supplies the monitors with batteries packed on an individual basis).
Approximately 230 monitors were supplied directly to parents. A further 63 monitors have been supplied to four hospitals, primarily for loan to parents to use at home. Additionally, two monitors were supplied to a Children's Centre and quadruplet monitors were supplied to a Primary Care Trust.
The MHRA is non aware of any infant deaths where this device was organism used.
The service update will admit checking the battery terminals and replacement them with the coil spring type as needful. The manufacturing business will pay for the return packaging and postage stamp of the monitor. You do non necessarily need to transmit the detector pad or the batteries.
The manufacturer's details are:
Axminster Electronics Ltd
Weycroft Avenue
Millwey Rise Industrial Estate
Axminster
Devon
EX13 5HU
Tel: 01297 32360
Fax: 01297 35454
E-mail:
