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Internal Handle 1011-0141-01Recalls & reported problems

Zoll Medical Corporation · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847946022716), received between Nov 1, 2019 and Nov 1, 2019 — classified as 1 death.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (1 report).

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 to Deliver Shock/Stimulation1

Patient problems

  • Death1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathNov 1, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN) DURING SURGERY, THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE INTERNAL HANDLES. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED; HOWEVER THEY DO NOT BELIEVE THIS WAS DEVICE ASSOCIATED.

    Patient problems: Death

    MAUDE report 9268723 ↗

Other Dc-defibrillator, low-energy, (including paddles) devices

All Dc-defibrillator, low-energy, (including paddles) devices →

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