| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00974-1 |
| Product Name/Description |
PAD 300/PAD 300P Public Access Defibrillators (PAD) (Semi-automated defibrillator)
Affected serial numbers: 0400000501 to 0700032917, 08A00035000 to 10A0070753 & 10C00200000 to 10C00210318
Manufactured between August 2004 and December 2010
ARTG Number: 156690 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
1.The device may turn itself on without input from the user. When this occurs, the normal sequence of audible prompts will be emitted from the device. If this issue continues undetected, the battery will eventually become completely depleted below the minimum battery capacity necessary to allow for the delivery of therapy.
2. Certain devices may misinterpret a temporary drop in battery voltage as signalling low battery. This issue will result in the device prematurely displaying the low battery warning and turning itself off even if sufficient battery capacity remains. If the low battery warning is triggered due to this issue, the device will have sufficient power to deliver multiple shocks, but it is possible that the device will only deliver one shock before turning itself off.
Devices containing software version 1.4.2/ 3.2.0 or higher are not susceptible to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Keep the devices in service. Follow the instructions from the sponsor to order a reserve battery pack and to download the new software. 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. For more details, please see http://www.tga.gov.au/safety/alerts-device-heartsine-pad300-pad300p-131010.htm . |
| Contact Information |
1800 628 881 - Aero Healthcare |