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Internal Handle 1011-0141-05-10Recalls & reported problems

Zoll Medical Corporation · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847946022983), received between Jan 4, 2022 and Jan 4, 2022 — classified as 1 malfunction.

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

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 4, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

    COMPLAINANT ALLEGED THAT DURING INCOMING TESTING, THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE ATTACHED INTERNAL HANDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13157096 ↗

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.