URGENT PRODUCT DEFECT CORRECTION
For HeartSine® Samaritan® Public Access Defibrillators.
- TGA Reference #: RC-2024-RN-00356-1
- ARTG #: 156690 – SAM 350P and SAM 500P | 228210 – SAM 360P
- Product Field Action #: RA 3540155
What is the issue?
A manufacturing related issue may impair device audio prompts. Stryker (the manufacturer) is issuing a customer notification to remind customers to follow the User Manual and power the device upon receipt to ensure the audio prompts function as intended.
Additional maintenance instructions are being issued a Maintenance Supplement to the User Manual, to ensure audio prompts function as intended:
Affected Products:
HeartSine® Samaritan Public Access Defibrillators 350P, 360P and 500P.
Problem:
The issue could prevent the device from delivering instructional voice prompts to the user during use of the device; however, the visual instructional icons will still be present and functioning. There has been one reported adverse event to date in which the device failed to deliver audio prompts.
Please note: There have been no adverse events reported in Australia/New Zealand.
DEVICES AFFECTED: This notice only applies to the scope of the Product Defect Correction is inclusive of devices with serial numbers that begin with the following prefixes:
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.
STEP 1: Please check the Prefix of your unit – found on the back of your unit per instruction below:
STEP 2: If the prefix on the notice is found on your unit, please check the PAD-PAK-03 reference and check EXPIRY date (Little hourglass)
STEP 3: IF YOUR PAD-PAK-03 has expired, please urgently replace by ordering here
STEP 4: View Steps in the below video to identify and Power cycle your device
PLEASE NOTE: If the video does not play for you, please down the Power cycle instructions here