HeartSine Samaritan PAD 360P SAM 360P (REF 360-STR-US-10)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05060167120688), 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 this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (P160008); they may or may not involve this specific model.

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 18, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, 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 ↗
• MalfunctionAug 17, 2023Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE ANY VOICE PROMPTS. WITHOUT VOICE PROMPTS, THE USER WOULD NOT ABLE TO USE THE DEVICE PROPERLY 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 17569320 ↗
• MalfunctionNov 21, 2022Failure 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 REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835537 ↗
• MalfunctionJun 15, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT THE DEVICE'S RIGHT PAD LED FAILED TO ILLUMINATE. THIS MAY CAUSE CONFUSION TO PAD PLACEMENT, WHICH MAY PREVENT OR DELAY DEFIBRILLATION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691775 ↗
• MalfunctionJan 4, 2022Battery Problem; Battery Problem

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE'S BATTERY WAS DEPLETED BEYOND USE. FAILURE TO POWER ON DEVICE MAY PREVENT OR DELAY DEFIBRILLATION THERAPY, 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 13158086 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160008. One submission often covers many models, so check the product and lot details in each record.

• Z-3120-2026 · Jul 27, 2026 · Open, Classified
  HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P U
• Z-3270-2026 · Jul 27, 2026 · Open, Classified
  HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (Americ
• Z-0288-2026 · Sep 18, 2025 · Open, Classified
  HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
• Z-2174-2025 · Jun 30, 2025 · Open, Classified
  HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan PAD (Public Access Defibrillator)
• Z-2143-2023 · Apr 26, 2023 · Open, Classified
  HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P
• Z-1217-2023 · Feb 1, 2023 · Open, Classified
  Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
• Z-0745-2022 · Jan 13, 2022 · Terminated
  HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak