Kendall 31469219 (UDI 20192253017455)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20192253017455), received between Jan 8, 2024 and Jan 25, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Sparking” (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 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.

• MalfunctionJan 25, 2024Loss of or Failure to Bond; Sparking; Loss of or Failure to Bond; Sparking

  THE CUSTOMER REPORTED THAT THE PATIENT WAS SHOCKED THREE TIMES SUCCESSFULLY AND ON THE FOURTH SHOCK, ARCING AND SPARKS CAME FROM THE PAD. IT WAS NOTED THAT THE PAD WAS POSSIBLY COMING OFF/NOT ADHERING WELL ON THAT FOURTH SHOCK. SHE DID SUSTAIN A SMALL AREA OF REDNESS TO HER SKIN AND WHEN CHECKING ON HER AT THE TRANSFER FACILITY, IT WAS NOTED TO STILL BE JUST RED WITH NO BLISTERING OR ANYTHING MORE SEVERE. THE PATIENT HAD NO CHEST HAIR AND WAS NOT DIAPHORETIC. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED.

  Patient problems: Erythema

  MAUDE report 18579942 ↗
• MalfunctionJan 8, 2024Sparking; Sparking

  THE CUSTOMER REPORTED THEY HAD A SCHEDULED CARDIOVERSION THAT USED A SET OF THE 31469219 PADS AND WHEN THE FIRST SHOCK WAS APPLIED, STAFF SAW A SPARK COME FROM THE PADS. THEY THOUGHT MAYBE THE PAD WAS COMING LOOSE AT THE BOTTOM WHERE THE CORDS ARE INSERTED, BUT THAT WASN¿T NOTICED UNTIL AFTER A SECOND SET WAS REMOVED FROM THE PACKAGING AND NOTED TO LOOK SIMILAR WITH THE LOOSE SEAL AT THE BOTTOM. THE SPARK DID NOT COME FROM THE BOTTOM OF THE PAD JUST TO MAKE THAT CLEAR. THEY SHAVED THE PATIENT, WHO WASN¿T REALLY TOO HAIRY ACCORDING TO NURSING STAFF AND APPLIED A THIRD SET OF PADS THAT DID WORK SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18468552 ↗