HeartSine Samaritan PAD 360PRecalls & reported problems across all models
Heartsine Technologies Ltd · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one HeartSine Samaritan PAD 360P model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of HeartSine Samaritan PAD 360P by Heartsine Technologies Ltd in the FDA's device registry (GUDID). Together they are named in 19 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2022 and Oct 16, 2025 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Audible Prompt/Feedback Problem” (6 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
HeartSine Samaritan PAD 360P recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 8, 2024Class IIOpen, Classified
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.
Z-1820-2024 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗
Most reported HeartSine Samaritan PAD 360P problems
Device problems
- Audible Prompt/Feedback Problem6
- Failure to Power Up6
- No Audible Prompt/Feedback5
- Electrical /Electronic Property Problem2
- Battery Problem1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
HeartSine Samaritan PAD 360P models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HeartSine Samaritan PAD 360P SAM 360PAutomated external defibrillators (non-wearable)1 recall19 reports
- HeartSine Samaritan PAD 360P SAM360PAutomated external defibrillators (non-wearable)1 recall0 reports
- HeartSine Samaritan PAD 360P SAM 360PAutomated external defibrillators (non-wearable)1 recall0 reports
- HeartSine Samaritan PAD 360P SAM 360PAutomated external defibrillators (non-wearable)1 recall0 reports
Recent HeartSine Samaritan PAD 360P adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEVICE WOULD NOT EMIT AUDIO PROMPTS WHEN POWERED ON. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23307664 ↗MalfunctionSep 15, 2025Connection Problem; Audible Prompt/Feedback Problem; Connection Problem; Audible Prompt/Feedback Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR PED PAK HAD NOT MADE PROPER CONTACT WITH THE DEVICE AND THAT CONSEQUENTLY THE DEVICE EXPERIENCED A RECURRING LOOP, REPEATEDLY PLAYING THE SAME VOICE PROMPT WITHOUT ADVANCING TO THE SUBSEQUENT STEP. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE. THE CUSTOMER CONFIRMED THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23059664 ↗MalfunctionJun 30, 2025Electrical /Electronic Property Problem; No Audible Prompt/Feedback; Electrical /Electronic Property Problem; No Audible Prompt/Feedback
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DID NOT BEGIN VOICE PROMPTS AND THE INSTRUCTIONAL LEDS FLASHED REPEATEDLY UPON POWERING THE DEVICE ON. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22367482 ↗MalfunctionJun 10, 2025Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22178298 ↗MalfunctionApr 10, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE PRODUCED NO AUDIO PROMPTS. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21814453 ↗MalfunctionMar 20, 2025Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE COULD NOT BE POWERED ON. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21653219 ↗MalfunctionDec 17, 2024Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE'S AUDIO PROMPTS WERE DISTORTED. WITH DISTORTED VOICE PROMPTS, A LAY USER MAY NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20953080 ↗MalfunctionDec 11, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE COULD NOT BE POWERED ON. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20907295 ↗MalfunctionNov 29, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE COULD NOT BE POWERED ON. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20810400 ↗MalfunctionNov 21, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DID NOT PROVIDE VOICE PROMPTS. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20745408 ↗MalfunctionJun 28, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DID NOT ISSUE VOICE PROMPTS. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19638960 ↗MalfunctionJun 25, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WAS UNABLE TO POWER ON. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19610195 ↗MalfunctionJun 4, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DID NOT EMIT AUDIO PROMPTS. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19458951 ↗MalfunctionSep 19, 2023Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DID NOT GIVE VOICE PROMPTS AS EXPECTED UPON START UP. THIS CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17778076 ↗MalfunctionAug 22, 2023Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR CUSTOMER'S DEVICE GAVE NO AUDIBLE MESSAGE. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY OR PREVENT DEFIBRILLATION FROM BEING DELIVERED. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17597706 ↗
Other Heartsine Technologies Ltd products
All Heartsine Technologies Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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