Kendall 31078135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884527007933), received between Oct 7, 2021 and Mar 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Analyze Signal” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER REPORTED THAT DURING USE, AN ECG WAS REQUESTED. THE ELECTRODES WERE PLACED ON THE PATIENT IN THE CORRECT PLACES AND DOUBLE CHECKED USING VERY CAREFUL ANATOMICAL LANDMARKS. DUE TO THE MALFUNCTION OF THE ELECTRODES, IT WAS POSSIBLE TO OBSERVE SEVERAL ARTIFACTS DURING THE READING OF THE ECG WHICH MADE THE READING INCOMPREHENSIBLE. SOMETIMES, THERE WAS ALSO AN ABSENCE OF CURRENT FLOW IN THE ELECTRODES WHICH CREATED AN ASYSTOLE, EVEN IF THE PATIENT WAS IN PERFECT HEALTH. A SECOND ECG MACHINE WAS TRIED, AND THE SAME MALFUNCTION WAS OBSERVED. THESE 2 ECGS HAVE BEEN VERIFIED BY A BIOMED TECH IN THE LAST FEW MONTHS. THE SAME TEST WITH A DIFFERENT LOT WAS DONE AND NO PROBLEMS WERE DETECTED WITH THE NEW LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685825 ↗
• MalfunctionOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THAT SHE HAD AN ALLERGIC REACTION TO THE ELECTRODE PATCHES AND HAS BURN LIKE INJURIES ON HER BODY. ADDITIONAL INFORMATION PROVIDED STATED THAT HER THROAT STARTED TO CLOSE MAKING THIS A LIFE THREATENING SITUATION. THE REACTION WAS LOCATED ON HER CHEST AND UNDER HER LEFT BREAST. SHE REACTED TO ALL FIVE ELECTRODES USED. SHE CONSULTED HER ALLERGIST BECAUSE SHE FELT SHORT OF BREATH. SHE WAS PRESCRIBED 50MG OF BENADRYL WHICH SHE TOOK EVERY EIGHT HOURS FOR TWO DAYS AND ONE DOSE OF 20MG OF PREDNISONE. SHE ALSO SELF-TREATED BY WASHING THE AREAS WITH SOAP AND WATER TO REMOVE THE GEL AND PATTED THE AREAS DRY. THE AREAS WERE BLISTERING SO SHE LEFT THEM OPEN IN THE AIR UNTIL SCABS FORMED. SHE NOW HAS SCARS IN THE AFFECTED AREAS.

  Patient problems: Blister; Dyspnea; Hypersensitivity/Allergic reaction; Scar Tissue

  MAUDE report 12594397 ↗