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

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Unlocated devices following recall for product correction

10 October 2013

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 to correct certain battery and software problems that may affect the ability of the device to work in the event it is needed.

HeartSine samaritan PAD

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:

040000504 040001000 0500002396 0500002571 0500002616
0500003386 0500015009 0600011981 0600012563 0600012565
0600015000 0600015002 0600015006 0600015008 0600015010
0600015013 0600015015 0600015038 0600015912 0600015913
0600015915 0600015916 0600015917 0600015918 0600015919
0600015920 0600015921 0600015922 0600015925 0600015926
0600015927 0600015929 0600015930 0600015932 0600015933
0600015934 0600015935 0600015936 0600015937 0600015938
0600015939 0600015940 0600015941 0600015942 0600015943
0600015944 0600015945 0600015946 0600015947 0600015948
0600015949 0600015950 0600015951 0600015952 0600015953
0600015954 0600015955 0600015956 0600015957 0600015973
0600015928 0700024347 0700048723 08A00036993 08A00037014
08A00037018 08A00037777 08A00040005 08A00040064 08A00040220
08A00041085 08A00041096 08A00041390 08A00041850 08A00042867
08A00042883 08A00044391 08A00044392 08A00044420 08A00044447
08A00045352 08A00045382 08A00045464 08A00045467 08A00059196
09A00049544 09A00049588 09A00049606 09A00052202 09A00052241
09A00052916 09A00052959 09A00053046 09A00053182 09A00055232
09A00055235 09A00055992 09A00056008 09A00056024 09A00056025
09A00056027 09A00058956 09A00059345 09A00060171 10A00066673
10A00067207 10C00201008 10C00201013 10C00201838 10C00201879
10C00202995 10C00203009 10C00203988 10C00203999 10C00204002
10C00204021 10C00204028 10C00204040 10C00206775 10C00206836

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.