First aiders warned of potentially faulty defibrillators

Defibrillators can be faulty
Published on Wednesday, 21 November 2012 10:03
Posted by Scott Buckler

First aiders in shopping centres, railways, dental surgeries and other public places are today being asked to identify defibrillators made by HeartSine Technologies Ltd

This is due to two potential faults with some defibrillators that could lead to depleted batteries and hence the device being unavailable for use in the event of a person having a sudden cardiac arrest in a public place.

Some samaritan® PAD 300/300P defibrillators are faulty because they may either turn on or off when not in use, which could drain the battery power. In addition, defibrillators with early versions of the battery management software may misinterpret a low battery voltage which could turn the defibrillator off.

The manufacturer, HeartSine Technologies Ltd, has issued a global correction notice for samaritan® PAD 300/300P defibrillators distributed from August 2004 to December 2010. Serial numbers for devices affected by these issues are below:

0400000501 to 0700032917 inclusive
08A00035000 to 10A00070753 inclusive
10C00200000 to 10C00210318 inclusive

No other HeartSine samaritan®PAD 300/300P defibrillators are affected by the issues that are the subject of this press release.

HeartSine Technologies Ltd has distributed 1387 samaritan® PAD 300/300P devices with the serial numbers listed above in the UK. HeartSine are issuing affected customers with a reserve battery so that emergency care can be given to patients in the event of a low battery and instructions on how the software can be upgraded.

John Wilkinson, the MHRA's Director of Medical Devices, 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.

"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 This email address is being protected from spambots. You need JavaScript enabled to view it.

Source: ©MHRA

 

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