PHILIPS HeartStart FR2+ 861459Recalls & reported problems
Philips Electronics North America Corporation · HS Refurbished FR2+ AED, no ECG · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884838050396), received between Jun 14, 2022 and Sep 11, 2026 — classified as 1 death, 5 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (2 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-Test2
- Battery Problem1
- Failure to Deliver Shock/Stimulation1
- No Audible Prompt/Feedback1
- Premature Discharge of Battery1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Cardiac Arrest1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 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 50736958 ↗MalfunctionMar 10, 2026No 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 24560513 ↗MalfunctionDec 11, 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 23778384 ↗MalfunctionAug 21, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT POWER ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22865693 ↗MalfunctionJun 13, 2025Battery Problem; Battery Problem
IT HAS BEEN REPORTED THAT THE DEVICE IS PREMATURELY DRAINING BATTERIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22204604 ↗DeathJun 14, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
THE USER IS DISAGREEING WITH THE "NO SHOCK ADVISED" NOTIFICATION GIVEN BY THE DEVICE DURING A PATIENT USE EVENT. THE EMERGENCY RESPONSE TEAM ARRIVED N SCENE AND WITH THEIR OWN EQUIPMENT, DELIVERED 6 SHOCKS. THE PATIENT DID NOT SURVIVE.
Patient problems: Cardiac Arrest
MAUDE report 14686266 ↗
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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