NA 989803109751Recalls & reported problems
Philips Medical Systems Hsg · Medium Switched Internal Paddles · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838003347), received between Dec 1, 2023 and Dec 1, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Electrical /Electronic Property 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.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem1
- Failure to Discharge1
Patient problems
- Tachycardia1
- Ventricular Fibrillation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2023Failure to Discharge; Electrical /Electronic Property Problem; Failure to Discharge; Electrical /Electronic Property Problem
IT WAS REPORTED THE RHYTHM OF A HEART SURGERY PATIENT CHANGED TO VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION AFTER DETACHMENT FROM THE PERFUSION MACHINE. AN ATTEMPT WAS MADE TO CHANGE THE PATIENT'S RHYTHM USING A DEFIBRILLATOR WITH ELECTRODE PADDLES PLACED ON THE SURFACE OF THE HEART. HOWEVER, THE DEVICE DID NOT DELIVER A SHOCK, AND THE PATIENT WAS BRIEFLY RECONNECTED TO THE PERFUSION MACHINE. THE DEFIBRILLATOR HAD BEEN SUCCESSFULLY CHECKED IN THE MORNING AS PER NORMAL PRACTICE. THERE IS SUSPICION THAT THE DEFIBRILLATOR PADDLES DID NOT FUNCTION. ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIFE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED.
Patient problems: Tachycardia; Ventricular Fibrillation
MAUDE report 18246668 ↗
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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