samaritan PADRecalls & reported problems across all models
Heartsine Technologies Ltd · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 304
- Deaths reported
- 7
- Injuries reported
- 2
- Recalls
- 0
We found 2 models of samaritan PAD by Heartsine Technologies Ltd in the FDA's device registry (GUDID). Together they are named in 304 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2017 and Sep 5, 2025 — classified as 7 deaths, 2 injuries, 295 malfunctions.
The most frequently reported specific device problem is “Defective Device” (154 reports).
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
Most reported samaritan PAD problems
Device problems
- Defective Device154
- Electrical /Electronic Property Problem43
- Self-Activation or Keying41
- Failure to Power Up38
- Protective Measures Problem32
- Device Operates Differently Than Expected23
- Noise, Audible23
- Battery Problem20
Patient problems
- No Patient Involvement203
- No Clinical Signs, Symptoms or Conditions105
- No Known Impact Or Consequence To Patient29
- Death8
- Cardiac Arrest5
- Insufficient Information3
- Ventricular Fibrillation3
- No Consequences Or Impact To Patient2
samaritan PAD models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- samaritan PAD SAM 350PAutomated External Defibrillators (Non-Wearable)6 deaths278 reports
- samaritan PAD SAM 450PAutomated External Defibrillators (Non-Wearable)1 death26 reports
Recent samaritan PAD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 5, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THEIR DEVICE STOPPED GIVING VOICE PROMPTS WHILE IN USE. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT. THIS ISSUE IS PATIENT RELATED AND THE PATIENT SURVIVED THE EVENT. THE CUSTOMER STATED THERE WAS A MEDICAL DELAY TO THERAPY.
Patient problems: Cardiac Arrest
MAUDE report 22982330 ↗MalfunctionOct 11, 2021Failure to Power Up; Electrical Power Problem; Failure to Power Up; Electrical Power Problem
THE DISTRIBUTOR CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE COULD NOT BE POWERED ON. INABILITY TO SWITCH ON A DEVICE MAY DELAY OR PREVENT DEFIBRILLATION THERAPY, WHICH COULD RESULT IN ADVERSE CONSEQUENCES. THE WAS NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12608401 ↗MalfunctionSep 14, 2021Failure to Power Up; Electrical Power Problem; Failure to Power Up; Electrical Power Problem
THE DISTRIBUTOR CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WAS FAILING TO POWER ON. FAILURE TO POWER ON DEVICE MAY PREVENT OR DELAY DEFIBRILLATION, WHICH COULD CAUSE AN ADVERSE EVENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12466194 ↗MalfunctionAug 13, 2021Defective Component; Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
THE DISTRIBUTOR CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WAS SHOWING THE "SHOCK KEY STUCK" ERROR MESSAGE. INABILITY TO USE THE DEVICE SHOCK BUTTON, MAY PREVENT OR DELAY DEFIBRILLATION WHICH COULD RESULT IN ADVERSE CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12317824 ↗MalfunctionJul 20, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
REPORTED THAT THE DEVICE IS NOT DELIVERING A SHOCK DURING TESTING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12194765 ↗MalfunctionJul 2, 2021Power Problem; Failure to Power Up; Power Problem
INABILITY TO SWITCH ON THE DEVICE COULD LEAD TO ADVERSE CONSEQUENCES FOR A PATIENT. NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12106030 ↗MalfunctionMay 14, 2021Device Displays Incorrect Message; Battery Problem
LOW BATTERY WARNING AND BEEP WITH IN DATE PAD-PAK. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11824258 ↗MalfunctionMay 6, 2021Defective Device; Device Displays Incorrect Message; Defective Device
RED STATUS LED AND DEVICE SERVICE PROMPT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11782085 ↗MalfunctionMay 6, 2021Defective Device; Noise, Audible; Defective Device
GREEN STATUS LED AND BEEP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11782084 ↗MalfunctionMay 6, 2021Electrical /Electronic Property Problem; Protective Measures Problem; Electrical /Electronic Property Problem
DEVICE SERVICE REQUIRED PROMPT, BEEPING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11782081 ↗MalfunctionMay 6, 2021Device Alarm System; Difficult to Insert; Failure to Power Up; Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
DIFFICULTY INSERTING PAD PAK. WHEN INSERTED THE RED STATUS LED WAS ILLUMINATED AND THE DEVICE WOULD NOT POWER ON. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11782077 ↗MalfunctionMay 6, 2021Failure to Shut Off
DEVICE WON'T SWITCH OFF. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11782075 ↗MalfunctionMay 6, 2021Defective Device
RED STATUS LED WITH NEW PAD-PAK. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11782010 ↗MalfunctionMay 4, 2021Failure to Power Up; Power Problem; Power Problem
DEVICE WILL NOT POWER ON WITH PAD-PAK BUT WILL WHEN OTHERS ARE USED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11768707 ↗MalfunctionMay 4, 2021Defective Device; Output Problem; Defective Device
GREEN STATUS LED AND BEEP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11768704 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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