PHILIPS HeartStart FR2+ with ECG 861458Recalls & reported problems
Philips Electronics North America Corporation · HS Refurbished FR2+ AED, with ECG · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884838050389), received between Feb 9, 2021 and Dec 11, 2025 — classified as 1 death, 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure of Device to Self-Test3
- Failure to Deliver Shock/Stimulation2
- Failure to Power Up1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Cardiac Arrest2
- Insufficient Information1
- Unspecified Heart Problem1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
IT HAS BEEN REPORTED THAT THE DEVICE DID NOT ADVISE A SHOCK ON A SHOCKABLE RHYTHM. THERE IS NO KNOWN HARM OR CONSEQUENCES TO THE PATIENT.
Patient problems: Cardiac Arrest
MAUDE report 23783906 ↗MalfunctionAug 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 22902362 ↗MalfunctionDec 21, 2023Failure 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 18372419 ↗MalfunctionMay 15, 2023Failure 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 16935921 ↗DeathMar 20, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
IT HAS BEEN REPORTED TP PHILIPS, THE DEVICE HAS A RED LIGHT, IMPOSSIBLE TO DELIVER SHOCK.
Patient problems: Cardiac Arrest; Unspecified Heart Problem
MAUDE report 16571622 ↗MalfunctionJan 14, 2022Failure 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 13260863 ↗MalfunctionFeb 9, 2021Therapeutic or Diagnostic Output Failure
IT HAS BEEN REPORTED THAT THE DEVICE SPEAKERS ARE NOT FUNCTIONING PROPERLY.
Patient problems: Insufficient Information
MAUDE report 11304178 ↗
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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