Kendall 31319281 (UDI 20192253017721)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20192253017721), received between Nov 8, 2022 and Dec 21, 2023 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Sparking; Sparking

  THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR ELECTRODE SPARKED DURING DEFIB. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS A DELAY IN SHOCK. THEY HAD TO APPLY ANOTHER SET OF PADS WHILE THE PATIENT WAS IN A LETHAL RHYTHM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375386 ↗
• MalfunctionAug 24, 2023Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER REPORTED THAT DURING A RESCUE OPERATION, THE ELECTRODE DID NOT DISSIPATE. IN A TEST WITH ANOTHER ELECTRODE FROM THE SAME BATCH, THERE WAS ALSO NO DERIVATION. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO SIGNAL. THERE WAS NO MEDICAL INTERVENTION REQUIRED. A SECOND DEFIBRILLATION DEVICE WAS AVAILABLE AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610611 ↗
• MalfunctionNov 8, 2022Failure to Sense; Failure to Sense

  THE CUSTOMER REPORTED THAT A MALE PATIENT WAS HAVING A PROCEDURE IN THE CVOR. HE WAS BEING MONITORED BY THE ANESTHESIA MONITOR AND THE DEFIBRILLATOR. THE PATIENT CODED AND WAS SHOCKED ONE TIME AT 200. THEN HE WAS SHOCKED A SECOND TIME AT 300 AND IMMEDIATELY AFTER THE SECOND SHOCK, THE DEFIBRILLATOR WAS NO LONGER MONITORING. THE PATIENT WAS STILL BEING MONITORED BY THE ANESTHESIA MONITOR. PER THE CUSTOMER, THE PATIENT EXPIRED BUT IT WAS NOT DUE TO THE ELECTRODE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 STATED THAT THE PROCEDURE BEING DONE WAS VATS. THE MONITOR BEING USED WAS A LIFEPAK 20E. THE MONITOR WAS STILL ON AND FUNCTIONING WITH NO SIGNAL FROM THE PADS. THE PATIENT'S CAUSE OF DEATH WAS DUE TO SEVERE LUNG AND CARDIAC DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756733 ↗