Heartsync by Vermed C100AC-PHYSIORecalls & reported problems
Graphic Controls Acquisition Corp · DEFIB ELECTRODE · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00009336009480), received between Jan 3, 2025 and Feb 11, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2025Sparking; Sparking
NURSE HEARD A BUZZING SOUND AND SAW A FLASH AT PAD DURING CARDIOVERSION. FLASH WAS AT EDGE OF BLUE WIRE AND A BLACK MARK WAS LEFT AT LOCATION. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21354201 ↗MalfunctionJan 3, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
END USER STATES THAT THE DEFIB PAD SEEMS TO NOT COMMUNICATE WITH THE LIFEPAK AND LOSES CONNECTION AT TIMES. IT WAS STATED THAT ONLY THIS LOT HAS BEEN AN ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21066322 ↗
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- 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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