PHILIPS HeartStart FRx 861304Recalls & reported problems
Philips Electronics North America Corporation · HeartStart FRx Defibrillator · Class 3
All models of PHILIPS HeartStart FRx (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Philips HeartStart FRx is an automated external defibrillator used in emergency heart care. The 356 reports mostly describe failed self-tests, the device working differently than expected, and units not powering up. The reports mention 6 deaths, no injuries and 350 malfunctions. 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
- 356
- Deaths reported
- 6
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 356 adverse event reports that list this exact device (DI 00884838006560), received between Nov 22, 2016 and Nov 12, 2025 — classified as 6 deaths, 350 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (197 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-Test197
- Device Operates Differently Than Expected67
- Incorrect, Inadequate or Imprecise Result or Readings46
- Failure to Power Up13
- Premature Discharge of Battery6
- Battery Problem3
- Defective Device3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Known Impact Or Consequence To Patient170
- No Clinical Signs, Symptoms or Conditions158
- Insufficient Information15
- Death6
- No Information4
- No Patient Involvement3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 356 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
THE DEVICE MAY NOT BE FUNCTIONING AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534626 ↗MalfunctionMay 19, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT HAS BEEN REPORTED THAT THE STATUS INDICATOR IS NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045165 ↗MalfunctionApr 2, 2025Premature Discharge of Battery; Premature Discharge of Battery
"IT WAS REPORTED THAT THE DEVICE WOULD POWER ON, BUT THE BATTERY POWER WAS LOW. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21755209 ↗MalfunctionMar 21, 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 21665682 ↗MalfunctionDec 31, 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 21048825 ↗MalfunctionOct 26, 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 20540435 ↗MalfunctionSep 3, 2024Intermittent Loss of Power; Intermittent Loss of Power
IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT POWER UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20128729 ↗MalfunctionJul 1, 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 19651363 ↗MalfunctionJun 6, 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 19480620 ↗MalfunctionApr 1, 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 19013365 ↗MalfunctionJan 29, 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 18603151 ↗MalfunctionJan 18, 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 18535394 ↗MalfunctionDec 7, 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 18283683 ↗MalfunctionNov 20, 2023Inaudible or Unclear Audible Prompt/Feedback; Inaudible or Unclear Audible Prompt/Feedback
IT HAS BEEN REPORTED THAT DEVICE SPEAKERS ARE NOT FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18175860 ↗MalfunctionNov 20, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS NOT RECOGNIZING THE PADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18170028 ↗MalfunctionNov 16, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150178 ↗MalfunctionOct 25, 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 18004203 ↗MalfunctionOct 24, 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 17998679 ↗MalfunctionOct 23, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17990571 ↗MalfunctionOct 16, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT HAS BEEN REPORTED THAT THE DEVICE IS DISCHARGING BATTERIES PREMATURELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17940593 ↗MalfunctionOct 6, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED TO PHILIPS THE CUSTOMER CALLED AND STATED THAT THE AED IS NOT WORKING PROPERLY. THE AED DOES NOT INITIATE A SELF-TEST WHEN THE BATTERY IS INSERTED. WHEN THE BATTERY IS INSERTED, THERE IS A SINGLE CHIRP AND NO PROMPTS. WHEN THE BLUE I BUTTON IS PRESSED THE AED STATES READY FOR USE. THIS IS OUTSIDE OF THE NORMAL SELF TEST OPERATION OF THE AED. THE AED IS TO BE EXCHANGED AT ZERO COST TO THE CUSTOMER UNDER IB WARRANTY EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17886662 ↗MalfunctionSep 20, 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 17786250 ↗MalfunctionSep 1, 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 17672326 ↗MalfunctionAug 14, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17546294 ↗MalfunctionAug 2, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED TO PHILIPS THE CUSTOMER CALLED AND STATED THAT THE AED IS NOT RECOGNIZING NEW PADS. THE CUSTOMER STATED THAT HE HAS PLACED SEVERAL SETS OF PADS ON THE AED AND THE AED KEEPS STATING THAT THE PADS ARE NOT USABLE WITH IN A MONTHS TIME PERIOD. THE LAST SET OF PADS WAS INSERTED (B)(6) 2023. THE AED IS UNDER WARRANTY AND TO BE EXCHANGED AT ZERO COST TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17440055 ↗
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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