PHILIPS HeartStart FR3Recalls & reported problems across all models
Philips Electronics North America Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,418
- Deaths reported
- 17
- Injuries reported
- 12
- Recalls
- 0
We found 2 models of PHILIPS HeartStart FR3 by Philips Electronics North America Corporation in the FDA's device registry (GUDID). Together they are named in 1,418 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Sep 25, 2026 — classified as 17 deaths, 12 injuries, 1,389 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (661 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PHILIPS HeartStart FR3 problems
Device problems
- Failure of Device to Self-Test661
- Inaudible or Unclear Audible Prompt/Feedback205
- Device Operates Differently Than Expected91
- Incorrect, Inadequate or Imprecise Result or Readings75
- Defective Component49
- Defective Device44
- Therapeutic or Diagnostic Output Failure34
- Inappropriate Audible Prompt/Feedback30
Patient problems
- No Clinical Signs, Symptoms or Conditions852
- No Known Impact Or Consequence To Patient398
- Insufficient Information105
- Cardiac Arrest40
- No Patient Involvement19
- No Information11
- Death10
- Tachycardia2
PHILIPS HeartStart FR3 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PHILIPS HeartStart FR3Automated External Defibrillators (Non-Wearable)10 deaths1,188 reports
- PHILIPS HeartStart FR3Automated External Defibrillators (Non-Wearable)7 deaths230 reports
Recent PHILIPS HeartStart FR3 adverse event reports
The 15 most recent reports across all models, 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 18, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828979 ↗MalfunctionSep 5, 2026Inaudible or Unclear Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50636313 ↗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, 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 ↗MalfunctionJul 27, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50008865 ↗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 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 ↗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 ↗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 ↗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 ↗
Other Philips Electronics North America Corporation products
All Philips Electronics North America Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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