PHILIPS HeartStart FR3 (REF 861389)Recalls & reported problems
Philips Electronics North America Corporation · HeartStart FR3 Defibrillator · Class 3
Quick summary
This Philips HeartStart FR3 is an automated external defibrillator, a portable device that delivers shocks to restart the heart. Many of its 1,186 reports describe the device failing its self-test, and others mention unclear voice prompts, battery problems, pads not being detected and a dim screen. The reports include 10 deaths and 9 injuries. No recalls name this device. Reports dropped from 39 in the previous 12 months to 16 in the last 12 months.
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
- 1,188
- Deaths reported
- 10
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,188 adverse event reports that list this exact device (DI 00884838049994), received between Nov 18, 2016 and Sep 25, 2026 — classified as 10 deaths, 9 injuries, 1,169 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (575 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure of Device to Self-Test575
- Inaudible or Unclear Audible Prompt/Feedback171
- Device Operates Differently Than Expected67
- Incorrect, Inadequate or Imprecise Result or Readings55
- Defective Device42
- Defective Component41
- Inappropriate Audible Prompt/Feedback26
- Therapeutic or Diagnostic Output Failure26
Patient problems
- No Clinical Signs, Symptoms or Conditions736
- No Known Impact Or Consequence To Patient320
- Insufficient Information85
- Cardiac Arrest33
- No Patient Involvement18
- No Information7
- Death4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 1,188 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Display or Visual Feedback Problem
It has been reported that the screen is dim.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893207 ↗MalfunctionSep 5, 2026Inaudible or Unclear Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50636313 ↗MalfunctionJul 27, 2026Inaudible or Unclear Audible Prompt/Feedback
It has been reported that the speaker volume is too soft.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038965 ↗MalfunctionJun 17, 2026Display Difficult to Read
IT HAS BEEN REPORTED THAT THE SCREEN IS DIM AND DIFFICULT TO READ.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25541583 ↗MalfunctionMay 18, 2026Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE PADS COULD NOT BE DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25205251 ↗InjuryApr 16, 2026Failure to Deliver Shock/Stimulation
THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A DELAY IN LIFE SAVING THERAPY AND WILL BE CONSIDERED A SERIOUS INJURY.
Patient problems: Cardiac Arrest
MAUDE report 24897319 ↗MalfunctionMar 31, 2026Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746316 ↗MalfunctionMar 30, 2026Battery Problem
IT HAS BEEN REPORTED THAT THE BATTERY IS NOT FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24734735 ↗MalfunctionMar 16, 2026Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613838 ↗MalfunctionFeb 24, 2026Failure to Run on Battery
IT HAS BEEN REPORTED THAT THE DEVICE'S BATTERY WILL NOT POWER UP AND THE BATTERY CANNOT BE RECHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430544 ↗MalfunctionJan 30, 2026No Visual Prompts/Feedback
IT HAS BEEN REPORTED THAT THE GREEN LED INDICATOR IS NOT FUNCTIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24222219 ↗MalfunctionJan 30, 2026No Visual Prompts/Feedback
IT HAS BEEN REPORTED THAT THE INDICATOR LIGHT IS NOT FUNCTIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221390 ↗MalfunctionJan 29, 2026Inaudible or Unclear Audible Prompt/Feedback
IT HAS BEEN REPORTED THAT THE DEVICE SPEAKERS ARE NOT FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24216586 ↗MalfunctionJan 12, 2026Premature Discharge of Battery
IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT POWER ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24046234 ↗MalfunctionDec 22, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23867151 ↗MalfunctionDec 1, 2025Display Difficult to Read; Display Difficult to Read
IT HAS BEEN REPORTED THAT THE SCREEN OF THE DEVICE IS NOT ILLUMINATING AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23685795 ↗MalfunctionDec 1, 2025Failure of Device to Self-Test; Intermittent Loss of Power; Failure of Device to Self-Test; Intermittent Loss of Power
IT HAS BEEN REPORTED THAT THE DEVICE HAS FAILED A SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23685794 ↗MalfunctionNov 10, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE MAY NOT BE FUNCTIONING AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23511794 ↗MalfunctionOct 27, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23390906 ↗MalfunctionAug 24, 2025No Display/Image; No Display/Image
IT HAS BEEN REPORTED THAT THE MONITOR WILL NOT POWER ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22881464 ↗MalfunctionJul 25, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22617684 ↗MalfunctionJul 24, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588948 ↗MalfunctionJul 1, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT HAS BEEN REPORTED THAT THE STATUS INDICATOR WAS NOT FUNCTIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22376120 ↗MalfunctionJun 10, 2025Failure to Run on Battery; Failure to Run on Battery
IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT POWER UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177523 ↗MalfunctionMay 20, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055483 ↗
Other Automated External Defibrillators (Non-Wearable) devices
- NA 861290Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)12 deaths5,167 reports
- NA 861288Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)21 deaths5,015 reports
- NA 861289Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)7 deaths3,385 reports
- R SERIES 30001005201310012Zoll Medical Corporation · Automated external defibrillators (non-wearable)10 deaths1,720 reports
- PHILIPS HeartStart FRxPhilips Electronics North America Corporation · Automated external defibrillators (non-wearable)26 deaths1,586 reports
- LIFEPAK CR2 99512Physio-Control, Inc. · Automated external defibrillators (non-wearable)8 deaths1,502 reports
- Lifeline Configuration DDU-100ADefibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)1 death1,285 reports
- AED PLUS 20000000100011010Zoll Medical Corporation · Automated external defibrillators (non-wearable)16 deaths1,072 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.