Regard™ T100AC-ZOLLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00326053105494), received between Dec 14, 2021 and Dec 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 14, 2021Patient-Device Incompatibility

  WHEN ZOLL PADS WERE PLACED ON THE PATIENT HE COMPLAINED OF EXTREME BURNING AND ITCHING. HE TRIED TO PULL THEM OFF. THEY TOOK ONE OFF WHICH WAS RED OUTSIDE THE OUTLINE OF THE PAD BUT NOT THE SECOND AND IT CAUSED A BLISTER THAT LATER BECAME A TEAR. THE SKIN WAS DRY, THEY DID NOT SHAVE AND SHE WASN'T SURE IF THEY PREPPED THE SKIN BEFORE PLACEMENT.

  Patient problems: Blister; Erythema; Itching Sensation; Skin Burning Sensation; Skin Tears

  MAUDE report 13006454 ↗