NA 861290Recalls & reported problems
Philips Medical Systems Hsg · HeartStart XL+ Defibrillator/Monitor · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Philips HeartStart XL+ is a non-wearable external defibrillator and monitor. Reports most often describe self-test failures, battery problems and failure to power up, and some mention warning messages. Some reports note no patient involvement. The device appears in 5,155 reports, including 12 deaths and 90 injuries. 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
- 5,167
- Deaths reported
- 12
- Injuries reported
- 90
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5,167 adverse event reports that list this exact device (DI 00884838023680), received between Nov 15, 2016 and Sep 30, 2026 — classified as 12 deaths, 90 injuries, 5,065 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (1,147 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-Test1,147
- Battery Problem422
- Electrical /Electronic Property Problem315
- Defibrillation/Stimulation Problem296
- Therapeutic or Diagnostic Output Failure292
- Failure to Power Up237
- Incorrect, Inadequate or Imprecise Result or Readings224
- Device Displays Incorrect Message194
Patient problems
- No Clinical Signs, Symptoms or Conditions3,450
- No Patient Involvement1,098
- No Known Impact Or Consequence To Patient379
- Insufficient Information129
- Unspecified Heart Problem41
- No Consequences Or Impact To Patient34
- Cardiac Arrest11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
Recent adverse event reports
The 25 most recent of 5,167 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Degraded
Philips received a complaint on the Defibrillator indicating that after the device had electrode damage. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942503 ↗MalfunctionSep 30, 2026Failure of Device to Self-Test
Philips received a complaint on the Defibrillator indicating that the self check failed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942502 ↗MalfunctionSep 30, 2026Failure of Device to Self-Test
Philips received a complaint on the Defibrillator indicating that after the device displays a cross and beep every 30 seconds. After the manual test, defibrillation test failed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941717 ↗MalfunctionSep 29, 2026Failure of Device to Self-Test
Philips received a complaint on the Defibrillator indicating that the self test failed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927548 ↗MalfunctionSep 28, 2026Failure to Deliver Shock/Stimulation
Philips received a complaint on the Defibrillator indicating that the device displays treatment implementation failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910817 ↗MalfunctionSep 28, 2026Failure to Deliver Shock/Stimulation
Philips received a complaint on the Defibrillator indicating that the device alarmed: therapy disabled. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910813 ↗MalfunctionSep 23, 2026Failure of Device to Self-Test
Philips received a complaint on the Defibrillator indicating that the device device alarmed self test failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864361 ↗MalfunctionSep 21, 2026Failure to Deliver Shock/Stimulation
Philips received a complaint on the Defibrillator indicating that the therapy test failed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835973 ↗MalfunctionSep 21, 2026Electrical /Electronic Property Problem
Philips received a complaint on the Defibrillator indicating that the device had external electrode failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835971 ↗MalfunctionSep 21, 2026Insufficient Device Problem Information
Philips received a complaint on the Defibrillator indicating that the device had an unspecified alarm. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835966 ↗MalfunctionSep 15, 2026Power Problem
Philips received a complaint on the Defibrillator indicating that the device prompts power supply equipment failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766659 ↗MalfunctionSep 14, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747964 ↗MalfunctionSep 11, 2026Battery Problem
Philips received a complaint on the Defibrillator indicating that the device had battery failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50726407 ↗MalfunctionSep 11, 2026Failure of Device to Self-Test
Philips received a complaint on the Defibrillator indicating that the device failed self test during bootup. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725953 ↗MalfunctionSep 10, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703490 ↗MalfunctionAug 31, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515027 ↗MalfunctionAug 24, 2026Defibrillation/Stimulation Problem
Philips received a complaint on the HeartStart XL+ Defibrillator indicating that a therapy disabled message was being emitted suggesting a fault in the therapy PCA. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50406148 ↗MalfunctionAug 16, 2026Unable to Obtain Readings
Philips received a complaint on the Defibrillator indicating that the device intermittently prompts ECG malfunction. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50268632 ↗MalfunctionAug 14, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261241 ↗MalfunctionJul 27, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015852 ↗MalfunctionJul 21, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25892028 ↗MalfunctionJul 1, 2026Failure of Device to Self-Test
PHILIPS RECEIVED A COMPLAINT REGARDING THE DEFIBRILLATOR INDICATING THAT THE DEVICE FAILS TO BOOT DUE TO SELF-TEST FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25676166 ↗MalfunctionJun 30, 2026Failure of Device to Self-Test
PHILIPS RECEIVED A COMPLAINT ON HEARTSTART XL+ DEFIBRILLATOR INDICATING THAT THE FUNCTIONAL TEST FAILED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25669172 ↗MalfunctionJun 17, 2026Failure of Device to Self-Test
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART XL+ DEFIBRILLATOR/MONITOR INDICATING THAT THE DEVICE FAILED THERAPY DELIVERY TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534042 ↗MalfunctionJun 17, 2026Complete Loss of Power; Intermittent Loss of Power
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART XL+ MONITOR/DEFIBRILLATOR INDICATING THAT THE DEVICE SHUTS DOWN ON ITS OWN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25533391 ↗
Other Automated External Defibrillators (Non-Wearable) devices
- 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
- AED PLUS 20000000100011010Zoll Medical Corporation · Automated external defibrillators (non-wearable)16 deaths1,072 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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