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E SERIES 50001730020174012Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, RAILS, VOICE, DMST · Class 3

All models of E SERIES (160)

Data updated Oct 18, 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 00847946009724), received between Jul 19, 2017 and May 3, 2018 — classified as 4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Failure of Device to Self-Test2
  • Failure to Power Up2
  • Loss of Power1

Patient problems

  • No Patient Involvement3
  • No Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 3, 2018Failure of Device to Self-Test; Failure of Device to Self-Test

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 7483962 ↗
  • MalfunctionFeb 2, 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 7237423 ↗
  • MalfunctionAug 4, 2017Failure of Device to Self-Test; Failure of Device to Self-Test

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 6767264 ↗
  • MalfunctionJul 19, 2017Loss of Power; Failure to Power Up; Loss of Power; Failure to Power Up

    COMPLAINANT ALLEGED THAT WHILE MONITORING A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN AND WOULD NOT POWER BACK UP. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE 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 6725488 ↗

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Sources and updates

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