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E SERIES 50011830020164013Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, NO RAILS, DMST · Class 3

All models of E SERIES (160)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847946011444), received between Apr 14, 2017 and Sep 11, 2020 — classified as 1 death, 5 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 18, 2026.

Most reported problems

Device problems

  • Failure to Power Up3
  • Incorrect Interpretation of Signal2
  • No Display/Image1

Patient problems

  • No Patient Involvement4
  • Death1
  • No Information1

Recent adverse event reports

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

  • MalfunctionSep 11, 2020Failure to Power Up; Failure to Power Up

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 10521698 ↗
  • MalfunctionDec 6, 2019Failure to Power Up; Failure to Power Up

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 9432792 ↗
  • MalfunctionNov 6, 2019Failure to Power Up; Failure to Power Up

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 9285862 ↗
  • DeathFeb 7, 2019Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) MALE PATIENT, THE DEVICE DELIVERED A SHOCK FOR A HEART RHYTHM THEY BELIEVED WAS NON-SHOCKABLE. COMPLAINANT INDICATED THAT RETURN OF SPONTANEOUS CIRCULATION WAS ESTABLISHED. HOWEVER, THE PATIENT SUBSEQUENTLY EXPIRED.

    Patient problems: Death

    MAUDE report 8317139 ↗
  • MalfunctionOct 17, 2018Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT AN UNRESPONSIVE (B)(6) YEAR OLD FEMALE PATIENT, THE DEVICE ISSUED A "SHOCK ADVISED" PROMPT FOR A HEART RHYTHM THEY BELIEVED WAS NON-SHOCKABLE. COMPLAINANT INDICATED THAT THE CLINICIAN SWITCHED TO MANUAL MODE TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Patient problems: No Information

    MAUDE report 7973618 ↗
  • MalfunctionApr 14, 2017No Display/Image; No Display/Image

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S DISPLAY WAS FROZEN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 6494491 ↗

Other Automated external defibrillators (non-wearable) devices

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Sources and updates

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