| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00243-1 |
| Product Name/Description |
Samaritan PAD 500P (Public Access Defibrillator)
Serial Numbers: 10B0010001 to 14B00461703
Manufactured between February 2010 and January 2014
ARTG Number: 156690 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
The software in the affected Samaritan® PAD 500P may miscalculate the CPR rate of compression per minute being administered to the patient. The rescuer may, therefore, be incorrectly advised by the device to “Push Slower” when, in fact, the CPR rate is at an acceptable level. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Aero Healthcare is advising users not to remove devices from service. Aero Healthcare is advising users that to address the issue an updated software version is available on the HeartSine Technologies website for download. Please follow the instructions provided by Aero Healthcare to download the new software. Alternatively, Aero Healthcare can provide an upgrade kit which includes a CD with the updated software version. |
| Contact Information |
1800 628 881 - Aero Healthcare |