NA 453564675561Recalls & reported problems
Philips Medical Systems Hsg · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838002753), received between Oct 15, 2018 and Oct 15, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Defibrillation/Stimulation Problem1
- Failure to Deliver Shock/Stimulation1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2018Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem
THE PATIENT WAS A CARDIAC ARREST. THE CODE TEAM ARRIVED AND INITIATED ADVANCED CARDIAC LIFE SUPPORT (ACLS) PROTOCOL. THE PATIENT'S RHYTHM CHANGED FROM PULSELESS ELECTRICAL ACTIVITY (PEA) TO VFIB AT 2332. RN ATTEMPTED TO CHARGE THE DEFIBRILLATOR TO 150J AND SHOCK, ONLY 120J WERE DELIVERED PER RHYTHM STRIP THAT WAS PRINTED. AFTER SHOCK DELIVERED THE DEFIBRILLATOR DID NOT SHOW A RHYTHM SO THE LEADS HAD TO BE PLACED ON THE PATIENT. THEN IT WAS DETERMINED THE PATIENT WAS IN SINUS RHYTHM.
Patient problems: No Code Available
MAUDE report 7965113 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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