Dental practices urged to check their defibrillators
Dental practices with a defibrillator made by HeartSine Technologies have been urged to check the serial number, as some devices could be faulty.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning after the manufacturer issued a global correction notice for Samaritan PAD 300/300P devices distributed between August 2004 and December 2010.
Affected serial numbers are: 0400000501 to 0700032917 inclusive; 08A00035000 to 10A00070753 inclusive; and 10C00200000 to 10C00210318 inclusive.
Many of these defibrillators are found in dental surgeries, shopping centres, railways and other public places, where they can be used in case of emergency.
But the manufacturer has drawn attention to two potential faults with the devices in question which could render them useless in the event of a person having a sudden cardiac arrest in a dental practice or public place.
The first possible problem is that some of the devices may turn on or off when not in use, causing the battery power to drain away.
In addition, those with early versions of the battery management software may misinterpret a low battery voltage, causing the defibrillator to turn off.
John Wilkinson, director of medical devices at the MHRA, said: "People who are responsible for these public access defibrillators that are in use at shopping centres, railway stations, dental surgeries and other public places need to check the serial numbers and, if they have an affected device, follow the advice in the manufacturer's field safety notice."
He added: "If the defibrillator is part of this corrective action and you are unsure of what to do, you can contact the manufacturer HeartSine on +44 02 8 9093 9400 or the MHRA Adverse Incident Centre on 020 7084 3080 or firstname.lastname@example.org."
A total of 1,387 devices are thought to be affected by the notice.
Affected customers are being issued with a reserve battery that can be used in the event of a low battery during an emergency.
HeartSine is also providing guidance on how to upgrade the battery management software for those with early versions.
Dental surgeries should be aware that having an automated external defibrillator is viewed by the Resuscitation Council UK as a minimum requirement.
This does not create a statutory obligation to have a defibrillator on-site, but indicates that failure to have such equipment could harm the practice's defence in the event that a collapsed patient is adversely affected.