Devices Regulator Warns Parents Of Faulty Baby Sleepsafe Monitors

Main Category: Pregnancy / Obstetrics
Also Included In: Medical Devices / Diagnostics;  Pediatrics / Children's Health
Article Date: 01 Sep 2008 - 0:00 PDT

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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 subsequently fail to monitor a baby's breathing.

A batch of AxminsteR Baby SleepSafe (Model AE 010 M) monitors was supplied with faulty battery terminals, which may fail if the monitor has been dropped. The battery terminals should be fitted with coil springs, to ensure good contact with the batteries. Monitors with the serial numbers between 001360 and 001660 should be returned to the manufacturer 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 breathing for 20 seconds an alarm should sound. These monitors are primarily designed for use in the home and are also used in some neonatal intensive care and special care baby units.

Other batches of the monitors are not affected as they were supplied with battery 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 ago and are usually used to monitor a baby's breathing up to one year old. The concern is that these monitors could be used on siblings or passed on to relatives or friends for use on their babies.

The manufacturer has contacted those hospitals to whom they have supplied the monitors directly 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 serial 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 check the battery terminals to make sure they are applying firm pressure to the batteries and are fitted with coil springs.

People can report any safety 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 adverse 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 also occur if the batteries are fitted incorrectly and the contacts are bent beyond their elastic limit. If the monitor is sent through the post with the batteries installed, damage can be caused to the terminal. (Note: - The manufacturer supplies the monitors with batteries packed separately).

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 four monitors were supplied to a Primary Care Trust.

The MHRA is not aware of any infant deaths where this device was being used.

The service update will include checking the battery terminals and replacing them with the coil spring type as required. The manufacturer will pay for the return packaging and postage of the monitor. You do not necessarily need to send the sensor 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: david@axminster-electronics.ltd.uk

The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone -the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

MHRA

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