Kendall 31469219 (UDI 20884527010315)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884527010315), received between Oct 31, 2019 and Mar 30, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2021Failure to Deliver Shock/Stimulation; Device Emits Odor; Sparking; Electrical Shorting; Failure to Deliver Shock/Stimulation; Device Emits Odor; Sparking; Electrical Shorting

  THE CUSTOMER REPORTED THAT THE DEFIBRILLATION ELECTRODES WERE CONNECTED TO A ZOLL MACHINE FOR CARDIOVERSION. WHEN SHOCK WAS SENT, THE CONNECTION SHORTED, SPARKED, AND THERE WAS A BURNING SMELL. THE ELECTRODES DID NOT DELIVER A SHOCK. THERE WAS A DELAY IN CARE AND A MINOR BURN TO PATIENT.

  Patient problems: Burn(s)

  MAUDE report 11592845 ↗
• MalfunctionSep 17, 2020Loss of or Failure to Bond; Thermal Decomposition of Device; Loss of or Failure to Bond; Thermal Decomposition of Device

  CUSTOMER REPORTS: DURING A CARDIOVERSION PROCEDURE ON A PATIENT, NURSING STAFF NOTICED THAT FUMES WERE EMANATING FROM THE PADS. OTHER ISSUES WITH THE PADS ARE THE SMELL OF FUMES DURING CARDIOVERSIONS, POPPING SOUND AND ARCHING COMING FROM MACHINE, WIRES BURNING AND THE ELECTRODE PADS DO NOT ADHERE WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10546611 ↗
• MalfunctionJan 16, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED THAT THE PHYSICIANS PERFORMED A CARDIOVERSION ON A PATIENT AND WHEN THE DEFIBRILLATOR PADS WERE INITIALLY PUT ON THE PATIENT, THE MACHINE READ "CHECK PADS". THE PAD'S WIRE WAS MANIPULATED AND THE RHYTHM STABILIZED, BUT THERE WAS STATIC ON THE SCREEN AND THEN IT STABILIZED. WHEN THE PADS SYNCED, THE MACHINE SEEMED FUNCTIONAL. THE PATIENT RECEIVED THE INTENDED SHOCK (WAS CARDIOVERTED) AT 200 JOULES BUT IMMEDIATELY AFTER THERE WAS A LOUD SNAPPING SOUND AND A BURNING ODOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9597678 ↗
• MalfunctionOct 31, 2019Failure to Deliver Energy; Arcing of Electrodes; Failure to Deliver Energy; Arcing of Electrodes

  THE CUSTOMER REPORTED THAT DURING A SYNCHRONIZED CARDIOVERSION, THE DEFIBRILLATOR PAD DID NOT DELIVER SHOCK BUT INSTEAD SPARKED AND BURNED THE PATIENT. THE PATIENT WAS GIVEN MINOR NURSING TREATMENT FOR A FIRST DEGREE BURN AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 9260267 ↗