samaritan PAD SAM 450PRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI M727SAM450P), received between Jun 7, 2018 and Mar 1, 2021 — classified as 1 death, 25 malfunctions.

The most frequently reported specific device problem is “Defective Device” (13 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem; Protective Measures Problem; Noise, Audible

  DEVICE BEEPING, INTERMITTENT GREEN/RED LED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391892 ↗
• MalfunctionMar 1, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem; Protective Measures Problem

  NO GREEN STATUS INDICATOR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391463 ↗
• MalfunctionJan 22, 2021Connection Problem

  CONNECTION FAIL BETWEEN GATEWAY AND SAM 450P. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11213522 ↗
• MalfunctionJan 22, 2021Failure to Power Up; Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  DEVICE FAILS TO POWER ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11213516 ↗
• MalfunctionNov 23, 2020Defective Alarm; Failure to Power Up; Defective Alarm

  THE STATUS INDICATOR FLASHED RED AND IT WAS FOUND THAT THE DEVICE COULD NOT TURN ON WHEN THE ON/OFF BUTTON WAS PRESSED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10883103 ↗
• MalfunctionNov 23, 2020Premature Discharge of Battery

  (HEARTSINE 450P) HAS DEPLETED ITS BATTERY WITHIN THE FIRST YEAR OF USE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10883101 ↗
• MalfunctionNov 5, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem; Self-Activation or Keying

  WHEN THE POWER IS TURNED ON IN THE SELF-TEST, ALL THE LAMPS LIGHT UP. THERE WAS NO PATIENT INVOLVED IN THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10792449 ↗
• MalfunctionOct 1, 2020Electrical /Electronic Property Problem; Defective Device; Electrical /Electronic Property Problem

  NO STATUS INDICATOR. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10611784 ↗
• MalfunctionSep 28, 2020Device Alarm System; Activation Problem; Device Alarm System; Activation Problem

  DEVICE SERVICE REQUIRED PROMPT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10592193 ↗
• MalfunctionSep 4, 2020Battery Problem

  THERE WAS NO PATIENT INVOLVED IN THIS EVENT.. THERE WAS AN ALERT ON THE DEVICE THAT THE BATTERY NEEDED TO BE REPLACED. USE UNTIL (B)(6) 2022 PAD PAK LOT # J0389.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10492916 ↗
• MalfunctionAug 17, 2020Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings; Electrical /Electronic Property Problem

  ALL LAMPS LIGHT UP IN SELF-TEST. THERE IS NO PATIENT INVOVLED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10412350 ↗
• MalfunctionAug 17, 2020Device Alarm System; Noise, Audible; Device Alarm System

  WE HEAR A SERIES OF 3 SHORT BEEPS COME FROM THE AED, WHILE IT IS SITTING IN OUR 70 DEGREE HOME. WHEN WE GET TO THE DEVICE, THE GREEN LIGHT IS BLINKING. THE CHECK IS ALWAYS NORMAL. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10412348 ↗
• MalfunctionApr 22, 2020Defective Device

  DEVICE FAILED TO SAVE AN EVENT ON (B)(6) 2020. PATIENT INVOLVED EVENT, NO IMPACT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9985537 ↗
• MalfunctionMar 10, 2020Defective Device; Therapeutic or Diagnostic Output Failure; Defective Device

  STATUS LED IS NOT BLINKING. (THE READINESS INDICATOR IS NOT BLINKING ON THIS DEVICE). NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9811033 ↗
• DeathJan 31, 2020Failure to Deliver Shock/Stimulation; Failure to Analyze Signal; Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THERE WAS A PATIENT INVOLVED IN THIS EVENT. A SAMARTIAN 450P DEVICE WAS USED DURING AN ALLEGED SCA IN THE USA. THE RESPONDER REMOVED PADS FROM DEVICE AND PLACED ON THE PATIENT. IT WAS ALLEGED THAT THE UNIT KEPT CYCLING THROUGH THE PROMPTS AND WOULD NOT PROGRESS TO ANALYZE FOR SHOCK THERAPY. THE RESPONDER USED AN ALTERNATIVE DEVICE TO PROVIDE THERAPY. CUSTOMER STATED THAT THE PATIENT DID NOT SURVIVE.

  Patient problems: Death

  MAUDE report 9652391 ↗
• MalfunctionNov 25, 2019Defective Device; Failure to Power Up; Defective Device

  DEVICE DOESN¿T TURN ON. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9368065 ↗
• MalfunctionAug 23, 2019Defective Device; Lack of Maintenance Documentation or Guidelines; Defective Device

  DEVICE SERVICE REQUIRED PROMPT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8924684 ↗
• MalfunctionJul 11, 2019Defective Device; Device Alarm System; Defective Device

  DEVICE BEEPING RED STATUS INDICATOR. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8780092 ↗
• MalfunctionJul 11, 2019Defective Device; Self-Activation or Keying; Defective Device

  UPON INSTALLATION, DEVICE SWITCHES ON AND FUNCTIONS BUT HAS NO GREEN STATUS INDICATOR. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8780091 ↗
• MalfunctionJun 4, 2019Device Alarm System

  NO STATUS INDICATOR PAD-PAK INSERTED CORRECTLY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8666087 ↗
• MalfunctionMay 8, 2019Failure to Power Up; Defective Device; Defective Device

  DEVICE WILL NOT SWITCH ON WITH NEW PAD-PAK 01 A3144. NO STATUS INDICATOR OR LEDS. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8590286 ↗
• MalfunctionMar 11, 2019Defective Device; Therapeutic or Diagnostic Output Failure; Defective Device

  RED STATUS INDICATOR AND BEEP, PAD-PAK EXPIRY MAY 2022. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8407580 ↗
• MalfunctionDec 6, 2018Defective Device; Failure to Power Up; Defective Device

  NO STATUS INDICATOR DEVICE WILL NOT SWITCH ON EVEN WITH ANOTHER PAD-PAK. REPORTABLE US ONLY.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8137020 ↗
• MalfunctionNov 25, 2018Defective Device

  DEVICE SERVICE REQUIRED PROMPT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8100415 ↗
• MalfunctionOct 29, 2018Defective Device; Defective Device; Protective Measures Problem

  DEVICE PROMPTS 'WARNING DEVICE SERVICE REQUIRED'. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8013460 ↗