NA 989803106981Recalls & reported problems
Philips Medical Systems Hsg · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20884838002757), received between Feb 4, 2023 and Dec 12, 2023 — classified as 3 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (7 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
- Defibrillation/Stimulation Problem7
Patient problems
- Burn(s)7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
CORRECTION: THIS REPORT HAS BEEN UPDATED FROM PRODUCT PROBLEM TO INJURY. THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS CUSTOMER SUPPORT PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT REGARDING THE PHILIPS HEARTSTART HANDS-FREE CABLE, INDICATING THAT A PATIENT SUSTAINED A BURN SIGN DURING A CARDIOVERSION PROCEDURE INVOLVING THE CABLE, AND BURNS ARE A KNOWN SIDE EFFECT OF CARDIOVERSION. THE DEVICE WAS IN USE ON A PATIENT. THIS COMPLAINT WAS LOGGED AGAINST THE HEARTSTART MRX ALS MONITOR (M3536A).
Patient problems: Burn(s)
MAUDE report 18315017 ↗InjurySep 11, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS CUSTOMER SUPPORT PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT REGARDING THE PHILIPS HEARTSTART HANDS-FREE CABLE, INDICATING THAT A PATIENT SUSTAINED A BURN SIGN DURING A CARDIOVERSION PROCEDURE INVOLVING THE CABLE, AND BURNS ARE A KNOWN SIDE EFFECT OF CARDIOVERSION. THE DEVICE WAS IN USE ON A PATIENT. THIS COMPLAINT WAS LOGGED AGAINST THE HEARTSTART MRX ALS MONITOR (M3536A).
Patient problems: Burn(s)
MAUDE report 17720926 ↗MalfunctionSep 11, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS CUSTOMER SUPPORT PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT REGARDING THE PHILIPS HEARTSTART HANDS-FREE CABLE, INDICATING THAT A PATIENT SUSTAINED A BURN SIGN DURING A CARDIOVERSION PROCEDURE INVOLVING THE CABLE, AND BURNS ARE A KNOWN SIDE EFFECT OF CARDIOVERSION. THE DEVICE WAS IN USE ON A PATIENT. THIS COMPLAINT WAS LOGGED AGAINST THE HEARTSTART MRX ALS MONITOR (M3536A).
Patient problems: Burn(s)
MAUDE report 17718729 ↗InjurySep 8, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS CUSTOMER SUPPORT PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT REGARDING THE PHILIPS HEARTSTART HANDS-FREE CABLE, INDICATING THAT A PATIENT SUSTAINED A BURN SIGN DURING A CARDIOVERSION PROCEDURE INVOLVING THE CABLE, AND BURNS ARE A KNOWN SIDE EFFECT OF CARDIOVERSION. THE DEVICE WAS IN USE ON A PATIENT. THIS COMPLAINT WAS LOGGED AGAINST THE HEARTSTART MRX ALS MONITOR (M3536A).
Patient problems: Burn(s)
MAUDE report 17716074 ↗InjuryMar 10, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
IT WAS REPORTED THERE WAS A PATIENT BURN SIGN AFTER CARDIOVERSION. THE DEVICE WAS IN USE ON A PATIENT.
Patient problems: Burn(s)
MAUDE report 16522247 ↗MalfunctionMar 10, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
IT WAS REPORTED THERE WAS A PATIENT BURN SIGN AFTER CARDIOVERSION. THE DEVICE WAS IN USE ON A PATIENT.
Patient problems: Burn(s)
MAUDE report 16522132 ↗MalfunctionFeb 4, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
IT WAS REPORTED THERE WAS A PATIENT BURN AFTER CARDIOVERSION. THE DEVICE WAS IN USE ON A PATIENT. ADDITIONAL DETAILS HAVE BEEN REQUESTED.
Patient problems: Burn(s)
MAUDE report 16301857 ↗
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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