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AED PLUS 20000100200000010Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN ASSY, PA SERIES, NO GRAPH, NO CPR,NO LCD, NO VOICE RCDG, ENGLISH · Class 3

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847946002213), received between Oct 18, 2017 and Jun 30, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Failure of Device to Self-Test2
  • Failure to Power Up2
  • Incorrect Interpretation of Signal1
  • Unexpected Shutdown1

Patient problems

  • No Patient Involvement4
  • No Information1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 30, 2020Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown

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

    Patient problems: No Patient Involvement

    MAUDE report 10212116 ↗
  • MalfunctionApr 29, 2020Failure 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 DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 10010550 ↗
  • MalfunctionDec 11, 2019Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Patient problems: No Information

    MAUDE report 9451062 ↗
  • MalfunctionJan 8, 2018Failure 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 Patient Involvement

    MAUDE report 7172640 ↗
  • MalfunctionOct 18, 2017Failure 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 6957763 ↗

Other Automated external defibrillators (non-wearable) devices

All Automated external defibrillators (non-wearable) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.