PHILIPS HeartStart FR3 (REF 861388)Recalls & reported problems
Philips Electronics North America Corporation · HeartStart FR3 Defibrillator · Class 3
Quick summary
This Philips HeartStart FR3 defibrillator has 230 adverse event reports, including 220 malfunctions, 3 injuries and 7 deaths. The reports mostly describe the unit failing its self-test or not powering on, unclear voice prompts, and operating differently than expected. Some reports describe a shock being delivered to a conscious patient. 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
- 230
- Deaths reported
- 7
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 00884838049987), received between Dec 12, 2016 and Sep 18, 2026 — classified as 7 deaths, 3 injuries, 220 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (86 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-Test86
- Inaudible or Unclear Audible Prompt/Feedback34
- Device Operates Differently Than Expected24
- Incorrect, Inadequate or Imprecise Result or Readings20
- Failure to Power Up9
- Defective Component8
- Therapeutic or Diagnostic Output Failure8
- Failure to Deliver Shock/Stimulation6
Patient problems
- No Clinical Signs, Symptoms or Conditions116
- No Known Impact Or Consequence To Patient78
- Insufficient Information20
- Cardiac Arrest7
- Death6
- No Information4
- No Patient Involvement1
- Tachycardia1
Recent adverse event reports
The 25 most recent of 230 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828979 ↗InjuryAug 4, 2026Inappropriate/Inadequate Shock/Stimulation
During a patient use event, the user is stating the device advised and delivered a shock on a conscious patient. The patient died 24 hours after the patient use event.
Patient problems: Cardiac Arrest
MAUDE report 50134117 ↗MalfunctionJul 27, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50008865 ↗InjuryApr 24, 2026Failure to Run on Battery
IT HAS BEEN REPORTED THAT THE DEVICE DID NOT POWER ON WHEN IT WAS RETRIEVED FOR A PATIENT USE EVENT. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Cardiac Arrest
MAUDE report 24987313 ↗MalfunctionApr 15, 2026Display or Visual Feedback Problem
IT HAS BEEN REPORTED THAT THE DEVICE STANDBY LIGHT NOT DISPLAYING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24889214 ↗MalfunctionFeb 12, 2026Complete Loss of Power
IT HAS BEEN REPORTED THAT THE DEVICE WOULD NOT POWER ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24324350 ↗MalfunctionFeb 5, 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 24269168 ↗MalfunctionNov 12, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT POWER ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23538663 ↗MalfunctionOct 29, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE HAS FAILED A SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23417291 ↗MalfunctionAug 1, 2025Failure to Power Up; Failure to Power Up
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 22692323 ↗MalfunctionJul 9, 2025Battery Problem; Battery Problem
IT HAS BEEN REPORTED THAT THE BATTERY IS NOT FUNCTIONING AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22462465 ↗MalfunctionMay 22, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT HAS BEEN REPORTED THAT THE BATTERY WAS PREMATURELY DRAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22074633 ↗MalfunctionMay 19, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE NEEDED AN UNKNOWN REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22047256 ↗MalfunctionMay 8, 2025No Display/Image; No Display/Image
IT HAS BEEN REPORTED THAT DEVICE'S SCREEN IS COMPLETELY DARK AND NOT FUNCTIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21987551 ↗MalfunctionApr 30, 2025Failure to Run on Battery; Failure to Run on Battery
IT HAS BEEN REPORTED THAT THE DEVICE WOULD NOT POWER ON THE BATTERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936661 ↗MalfunctionApr 23, 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 21894403 ↗MalfunctionApr 17, 2025Failure to Power Up; Failure to Power Up
IT HAS BEEN REPORTED THAT THE DEVICE WOULD NOT POWER ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21858817 ↗MalfunctionApr 4, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE BATTERY WAS DRAINED AND/OR DID NOT WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21774882 ↗MalfunctionApr 3, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT HAS BEEN REPORTED THAT THE AED BATTERY HAS PREMATURELY DRAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21762241 ↗MalfunctionMar 14, 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 21605485 ↗MalfunctionJul 25, 2024Failure to Power Up; Failure to Power Up
IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT POWER UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19832774 ↗MalfunctionJul 25, 2024Failure 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 19827975 ↗MalfunctionMay 7, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS DISPLAYING A FAULT CODE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19263927 ↗MalfunctionMar 23, 2024Failure 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 18966369 ↗MalfunctionMar 20, 2024Failure 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 18942091 ↗
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
- PHILIPS HeartStart FR3Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)10 deaths1,188 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.