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E SERIES 80001730020164013Recalls & reported problems

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

All models of E SERIES (160)

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

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847946015671), received between Jun 22, 2017 and Oct 3, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (5 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 Up5
  • Improper Alarm1
  • Unexpected Shutdown1

Patient problems

  • No Patient Involvement6
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 3, 2019Failure to Power Up; Failure to Power Up

    COMPLAINANT ALLEGED THAT DURING INCOMING 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 9153519 ↗
  • MalfunctionDec 6, 2018Unexpected Shutdown; Unexpected Shutdown

    COMPLAINANT ALLEGED THAT WHILE MONITORING A PATIENT (AGE & GENDER UNKNOWN) DURING TRANSPORT IN AN AMBULANCE, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE CLINICIAN PLUGGED THE DEVICE TO THE INVERTER IN THE AMBULANCE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8137513 ↗
  • MalfunctionOct 3, 2018Failure 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 7929715 ↗
  • MalfunctionAug 21, 2018Failure to Power Up; Failure to Power Up

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 7801967 ↗
  • MalfunctionMar 2, 2018Failure to Power Up; Failure to Power Up

    COMPLAINANT ALLEGED THAT DURING INCOMING 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 7310328 ↗
  • MalfunctionOct 10, 2017Failure to Power Up; Failure to Power Up

    COMPLAINANT ALLEGED THAT 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 6938437 ↗
  • MalfunctionJun 22, 2017Improper Alarm; Improper Alarm

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "DEFIB FAULT 196" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 6661035 ↗

Other Automated external defibrillators (non-wearable) devices

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Sources and updates

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