AED PLUS 22800810102011010Recalls & reported problems
Zoll Medical Corporation · AED PLUS, PS SERIES, ECG ON, W/PA CVR, LCD, NO VOICE RCDG, PlusRX, DMST · Class 3
All models of AED PLUS (30)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847946056421), received between Jan 6, 2026 and May 11, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Power Up3
- Use of Device Problem2
- Failure to Analyze Signal1
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135502 ↗MalfunctionFeb 18, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD INTERMITTENTLY NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24379550 ↗MalfunctionJan 9, 2026Unable to Obtain Readings; Failure to Analyze Signal; Use of Device Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 71-YEAR OLD MALE PATIENT, THE DEVICE DISPLAYED A "CHECK PADS" MESSAGE AND WAS UNABLE TO ANALYZE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24026979 ↗MalfunctionJan 6, 2026Failure to Power Up; Use of Device Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED TO POWER ON DURING THE CODE.
Patient problems: Insufficient Information
MAUDE report 23982500 ↗
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- 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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