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AED PLUS 20000001100011010Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN ASSY, PS SERIES, LCD, VOICE, RCDG, ENGLISH · Class 3

All models of AED PLUS (30)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
2
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847946002183), received between Apr 30, 2018 and Jul 28, 2023 — classified as 2 deaths, 4 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (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.

Most reported problems

Device problems

  • Failure of Device to Self-Test3
  • Failure to Deliver Shock/Stimulation1
  • Failure to Power Up1
  • Unable to Obtain Readings1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Patient Involvement2
  • Death1
  • Necrosis1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 28, 2023Failure of Device to Self-Test; Failure of Device to Self-Test

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17413913 ↗
  • DeathApr 19, 2023Unable to Obtain Readings; Unable to Obtain Readings

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY DISPLAYED AN "ATTACH PADS" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Patient problems: Necrosis

    MAUDE report 16768645 ↗
  • MalfunctionOct 12, 2021Failure of Device to Self-Test; Failure of Device to Self-Test

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12618797 ↗
  • DeathOct 28, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Patient problems: Death

    MAUDE report 9247637 ↗
  • MalfunctionJun 25, 2019Failure to Power Up; Failure to Power Up

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8730721 ↗
  • MalfunctionApr 30, 2018Failure of Device to Self-Test; Failure of Device to Self-Test

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE INTERMITTENTLY PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 7472870 ↗

Other Automated external defibrillators (non-wearable) devices

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Sources and updates

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