samaritan PAD SAM 350PRecalls & reported problems

Heartsine Technologies Ltd · Semi-Automatic External Defibrillator · Class 3

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Heartsine samaritan PAD SAM 350P is a semi-automatic external defibrillator, a device used to deliver a shock to restart the heart. Of its 278 reports, 270 are malfunction reports, often describing the unit failing to power on, switching itself on, or not delivering a shock, and 2 are injury reports, one describing voice prompts stopping mid-use. There were 6 deaths reported. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 278
Deaths reported: 6
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 278 adverse event reports that list this exact device (DI M727SAM350P), received between Apr 11, 2017 and Sep 5, 2025 — classified as 6 deaths, 2 injuries, 270 malfunctions.

The most frequently reported specific device problem is “Defective Device” (141 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Defective Device141
Self-Activation or Keying39
Electrical /Electronic Property Problem38
Failure to Power Up33
Protective Measures Problem29
Device Operates Differently Than Expected22
Noise, Audible21
Battery Problem19

Patient problems

No Patient Involvement188
No Clinical Signs, Symptoms or Conditions93
No Known Impact Or Consequence To Patient28
Death7
Cardiac Arrest5
Insufficient Information3
Ventricular Fibrillation3
Asystole1

Recent adverse event reports

The 25 most recent of 278 reports, 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 ↗
MalfunctionMay 4, 2021Failure to Power Up; Failure to Shut Off; Failure to Shut Off
DEVICE WON'T POWER OFF. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11768701 ↗
MalfunctionMay 4, 2021Battery Problem; Electrical Power Problem; Electrical Power Problem
LOW BATTERY PROMPT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11768695 ↗
MalfunctionApr 15, 2021Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem
DEVICE SERVICE REQUIRED PROMPT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11671595 ↗
MalfunctionApr 15, 2021Electrical /Electronic Property Problem; Output Problem; Electrical /Electronic Property Problem
INTERMITTENT STATUS LED AND BEEP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11671583 ↗
MalfunctionApr 7, 2021Defective Device; Protective Measures Problem; Defective Device
GREEN STATUS LED AND BEEP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628492 ↗
MalfunctionApr 7, 2021Electrical /Electronic Property Problem; Self-Activation or Keying; Electrical /Electronic Property Problem
DEVICE SWITCHES ON AUTOMATICALLY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628487 ↗
MalfunctionApr 7, 2021Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem
RED STATUS LED AND BEEP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628486 ↗
MalfunctionApr 7, 2021Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Defective Component; Display or Visual Feedback Problem; Electrical /Electronic Property Problem
NO STATUS LED. NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628483 ↗
MalfunctionApr 7, 2021Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem
RED STATUS INDICATOR. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628482 ↗
MalfunctionApr 7, 2021Self-Activation or Keying; Defective Device; Defective Device
DEVICE SWITCHING ON AUTOMATICALLY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628476 ↗

Device details

UDI-DI	`M727SAM350P`
Brand	samaritan PAD
Model	SAM 350P
Company	Heartsine Technologies Ltd
Product code	MKJ · Automated External Defibrillators (Non-Wearable)
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Non-rechargeable public semi-automated external defibrillator

A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. It is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of two skin-adhesive, cartridge-type, disposable electrodes containing non-rechargeable batteries that provide the shock energy, and an electrode-regulating external pulse generator (EPG), which may include a CPR feedback.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
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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