Product correction: HeartSine samaritan Public Access Defibrillators (PAD) 350P, 360P, 500P
What is the problem?
Stryker is conducting an Urgent Product Correction (RC-2024-RN-00356-1) of certain lots of the HeartSine Defibrillator. This action originally commenced in May 2024. Stryker is now attempting to reach a small percentage of customers who cannot be identified.
A manufacturing related problem may impair device audio prompts and prevent the device from delivering instructional voice prompts to the user during use.
| ARTG Number | Catalog number | Product model | Affected serial numbers |
|---|---|---|---|
| 156690, 228210 | 350BASUK10 350BASUKGW | HeartSine SAM 350P | Affected devices begin with the following prefixes and device codes: 16B, 16C, 16D, 16E, 16G, 16H 17B, 17D, 17E, 17G, 17H 18B, 18D, 18E, 18G, 18H 19B, 19D, 19E, 19G, 19H 20B, 20D, 20E, 20G, 20H 21B, 21D, 21E, 21G, 21H 22B, 22D, 22E, 22G, 22H 23B, 23D, 23E, 23G, 23H 24B, 24D, 24E, 24G, 24H |
360BASSJ10 360BASUK10 360BASUKGW 360STRUK10 | HeartSine SAM 360P | ||
500BASUK10 500BASUKGW | HeartSine SAM 500P |
What are the risks?
The problem could lead to:
- No shock delivery due to user inaction.
- Excessive delay in shock delivery.
- Minor delay in shock delivery.
What should I do?
- Follow the User Manual and power the device upon receipt to ensure the audio prompts function as intended.
- In the event the device does not have any audio prompts, you can still refer to the visual instruction icons and quick user guide to attempt treatment.
- Complete an audio prompt check once every three months. This can be done quickly without removing the AED from its case.
- Be aware of the Maintenance Supplement, available at HeartSine Automated External Defibrillators.
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.