Recall: Pad-Pak battery for HeartSine samaritan Public Access Defibrillator (PAD)
What is the problem?
Stryker is conducting an Urgent Recall (RC-2023-RN-00695-1) of certain lots of the HeartSine Samaritan Public Access Defibrillator Pak (PAD-PAK). This action originally commenced in August 2023. Stryker is now attempting to reach a small percentage of customers who cannot be identified.
The affected Pad-Paks may not work due to prematurely depleted battery cells.
| ARTG Number | Catalog number | Product Name | Affected lot numbers |
|---|---|---|---|
| 338960 | PAD-PAK-03 | BATTERY HeartSine samaritan PAD (Public Access Defibrillator) Pak (Pad-Pak) | A3644, A3654, A3655, A3659, A3660, A3664, A3765, A3803, A3840, A3842, A3843, A3844, A3845, A3846, A3847, A3848, A3849, J0748, J0752, J0754, J0755, J0756. |
What are the risks?
The affected Pad-Paks could potentially fail to power on the HeartSine samaritan PAD if it is needed for use. This could prevent the device from analysing the patient condition or delivering therapy correctly.
What should I do?
- If you have any of the above lot numbers, contact Stryker via email on postmarketssp@stryker.com or call on 02 9170 9162 to arrange for a replacement.
- Continue monitoring your HeartSine samaritan PAD device/s to ensure the status indicator is flashing green every 5 to 10 seconds.
- Contact Stryker immediately if you identify either of the following situations:
- If the status indicator is flashing red or you hear continuous beeping or the voice prompt “Warning, Low Battery”.
- If there is no status indicator displayed.
- Once you receive the replacement Pad-Pak/s, please dispose of the affected Pad-Pak/s.
Further information
Please contact Stryker on 02 9170 9162 or email postmarketssp@stryker.com for further information.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our 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.