HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P

FDA device recall Z-1820-2024 · posted 2024-05-14 · Open, Classified

Recall details

Recalling firm

HeartSine Technologies Ltd

Reason for recall

Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.

Action taken

On 04/08/24 Stryker sent correction notices to customers informing them of the following: 1) Follow instructions to power cycle affected devices: a) Check the expiration date on the Pad-Pak and if passed, do not use and replace the expired Pad-Pak. b) Place the affected device face up on a flat surface and slide the Pad-Pak into the affected device until you hear the "double click." c) Verify that the green Status indicator is blinking to indicate the initial self-test routine has been performed and the device is ready for use. d) Press On/Off button. c) Listen for, but do not follow, voice prompts. -If you do not hear a prompt, contact your Authorized Distributor or HeartSine Technologies Technical Support at: heartsinesupport@stryker.com -If you hear prompt "Adult patient" and/or "Call for medical assistance", no further action is needed. d) Press On/Off button. If you have not heard a warning message and the status indicator continues to flash green, the device is ready for use. e) Carry out check once every three months and maintain awareness. f) Audio issue will not cause a warning message, but if any other warning messages are played, or you see a red flashing status indicator, please refer to User Manual (General Troubleshooting). 2) Complete/return the response form to RSRecall@stryker.com. 3) If further distributed, email to RSRecall@stryker.com. Stryker will work with you to ensure recipients are notified. 4) If you have any questions or concerns, contact Customer Support at +44 28 9093 9400, 9A.M. to 5P.M. (GMT), or by email at RSRecall@stryker.com. On 3/17/2025, additional correction notices were sent and in addition customers were informed: - Keep track of the total number of impacted devices as well as the number of devices that do not provide audio prompts (if any). - If unable to complete this check every 3 months, please reach out to RSRecall@stryker.com for further alternative solutions that may be applied.

Root cause

Process control

Status

Open, Classified

Product code

MKJ

Quantity affected

183,248

Distribution

US Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV

Date initiated

2024-04-08

Date posted

2024-05-14

Location

Belfast, United Kingdom