HeartSine PAD 300/PAD 300P public access defibrillators (semi-automated)

Owners and people responsible for HeartSine PAD 300/PAD 300P public access defibrillators are advised that Aero Healthcare, in consultation with the TGA, undertook a recall for product correction of some of these devices in November 2012 - external site to correct certain battery and software problems that may affect the ability of the device to work in the event it is needed.

Automated external defibrillators are used in cases of life-threatening cardiac arrhythmia which lead to cardiac arrest. Public access defibrillators are typically found in areas where large numbers of people congregate – such as offices, shopping centres, transport hubs and sporting facilities – and are designed to be used by people with limited or no training.

Aero Healthcare has advised the TGA that there are about 120 HeartSine PAD 300/PAD 300P units which could not be located during the recall. Some of these were distributed by Weinmann Australia which is no longer in operation.

Devices affected by the recall action were manufactured between August 2004 and December 2010.

The serial numbers of the defibrillators still to be located are:

Information for owners and controllers of HeartSine PAD 300/PAD 300P public access defibrillators

If you own, or are responsible for, a HeartSine PAD 300/PAD 300P you should check the serial number against the above list. The serial number is located on the bottom of the device under the bar code.

If your unit is included in the recall, contact Aero Healthcare on 1800 628 881.

While waiting for Aero Healthcare to complete corrective action you should:

• Keep the device in service.
• If necessary, relocate the device to an area where the audible prompts of it turning on/off would be heard if initiated.
• Increase device check frequency to daily to confirm that the device is operating properly and is in ready standby mode.

Aero Health will advise customers on any further steps that should be taken.

Information for consumers and health professionals

The majority of the HeartSine PAD 300/PAD 300P devices affected by the 2012 recall have already been located.

Some of the devices still to be located may no longer be in use as they have passed their expiry dates.

This advisory is to ensure that Aero Healthcare can locate and correct the problem in all HeartSine PAD 300/PAD 300P public access defibrillators to ensure they function properly if needed during a cardiac event.

Information about the 2012 recall

The recall was to address two issues:

• Some HeartSine PAD 300/PAD 300P devices intermittently turn on and off while on standby, draining the battery over time and potentially preventing use when needed during a cardiac event.
• Some devices containing early versions of the battery management software misinterpreted a temporary drop in battery voltage as signalling a low battery, also potentially preventing effective use during a cardiac event. The false low battery signal may discourage rescuers from persisting with a working device. Devices containing software version 1.4.2/3.2.0 or higher are not susceptible to the issue.

Aero Healthcare is undertaking the following activities as part of the recall:

• if a device shows signs of the on-off problem, Aero will provide a replacement unit
• Aero will supply a reserve 1500 mAh PAD-PAK battery, along with a hang-tag with instructions on how to change batteries, if required
• Aero will supply a data cable, allowing customers to update a unit's software via the internet or a supplied disc.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.